Second Opinion: A Case-Based Exploration of Clinical Investigator Best Practices Related to the Use of PI3K/AKT/mTOR Inhibitors for HR-Positive Breast Cancer

A CME Satellite Symposium

Program Schedule — Central Time
Tuesday, December 8, 2026
6:30 PM – 7:00 PM — Registration and Dinner Buffet
7:00 PM – 9:00 PM — Educational Meeting

Location
San Antonio Marriott Rivercenter
101 Bowie St
San Antonio, Texas
Hotel Phone: (210) 223-1000

Meeting Room
To be announced.

No registration fee. Preregistration is required for in-person attendance in San Antonio as seating is limited.

Sara A Hurvitz

Faculty

Sara A Hurvitz

MD, FACP

Fred Hutchinson Cancer Center, Seattle, Washington

Professor of Medicine, Smith Family Endowed Chair in Women’s Health, Senior Vice President, Clinical Research Division

UW Medicine, Seattle, Washington

Head, Division of Hematology/Oncology, Department of Medicine

Komal Jhaveri

Faculty

Komal Jhaveri

MD, FACP, FASCO

Memorial Sloan Kettering Cancer Center, New York, New York

Patricia and James Cayne Chair for Junior Faculty, Associate Attending Physician, Breast Medicine Service and Early Drug Development Service, Section Head, Endocrine Therapy Research Program

Weill Cornell College of Medicine, New York, New York

Associate Professor of Medicine

Nicholas Turner

Faculty

Nicholas Turner

MD, PhD

The Royal Marsden and ICR NIHR Biomedical Research Centre, London, United Kingdom

Director

The Royal Marsden NHS Foundation Trust

Director of Clinical Research

The Institute of Cancer Research, London, United Kingdom

Professor of Molecular Oncology, Director of Clinical Research

Hope S Rugo

Moderator

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

This symposium is sponsored by Research To Practice and supported by grants from AstraZeneca Pharmaceuticals LP, Celcuity, and Genentech, a member of the Roche Group. This is not an official program of the San Antonio Breast Cancer Symposium®.

Join us on Tuesday, December 8th from 7:00 PM to 9:00 PM central time (8:00 PM to 10:00 PM eastern time).

Module 1: Identification and Management of Newly Diagnosed Hormone Receptor (HR)-Positive Metastatic Breast Cancer (mBC) Harboring a PIK3CA Mutation 

  • Optimal methodology and timing of testing to identify PI3K/AKT/PTEN alterations in patients with HR-positive, HER2-negative mBC 
  • Mechanistic similarities and differences between inavolisib and earlier-generation PI3K inhibitors such as alpelisib; implications for efficacy and tolerability 
  • Design, eligibility criteria and key efficacy findings, including overall survival outcomes, from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib and fulvestrant as first-line therapy for patients with endocrine-resistant, PIK3CA-mutant, HR-positive, HER2-negative mBC 
  • FDA approval of inavolisib/palbociclib/fulvestrant and current clinical role for newly diagnosed HR-positive, HER2-negative mBC with a PIK3CA mutation 
  • Ongoing Phase III trials (INAVO123, CAPItello-292, VIKTORIA-2) evaluating PI3K/AKT/mTOR inhibitors as a component of first-line therapy for patients with HR-positive, HER2-negative mBC; estimated completion dates 

Module 2: Current Management of Progressive HR-Positive mBC with a PI3K/AKT/PTEN Alteration 

  • Mechanism of action of the AKT inhibitor capivasertib; implications for target selectivity and antitumor activity compared to the PI3K inhibitors inavolisib and alpelisib 
  • Available efficacy findings, including final overall survival data, from the Phase III CAPItello-291 trial establishing the clinical benefit of capivasertib/fulvestrant for progressive HR-positive, HER2-negative mBC with PI3K/AKT/PTEN alterations 
  • FDA approval of capivasertib and current clinical role opposite other evidence-based options 
  • Mechanistic similarities and differences between the novel dual PI3K/mTOR inhibitor gedatolisib and currently approved PI3K/AKT/mTOR inhibitors; implications for antitumor activity and tolerability 
  • Design, eligibility criteria and primary and secondary endpoints of the Phase III VIKTORIA-1 trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib for patients with HR-positive, HER2-negative advanced breast cancer whose disease progressed on or after prior CDK4/6 inhibitor therapy and an aromatase inhibitor; FDA approval and optimal incorporation into clinical practice 
  • Efficacy and safety findings from the PIK3CA-mutated cohort of VIKTORIA-1; anticipated full presentation of results and future role of gedatolisib-containing combination therapy 
  • Other Phase III efforts investigating promising novel agents and strategies for HR-positive mBC harboring PI3K/AKT/PTEN alterations 

Module 3: Optimal Approaches to the Management of Progressive PIK3CA Wild-Type, HR-Positive Disease 

  • Historical outcomes with standard second-line regimens for HR-positive, HER2-negative mBC with no actionable alterations 
  • Available data with and current role, if any, of CDK4/6 inhibitor continuation or rechallenge for patients with HR-positive, HER2-negative mBC progressing on first-line treatment with a CDK4/6 inhibitor and endocrine therapy 
  • Rationale for the evaluation of gedatolisib-containing regimens for PIK3CA wild-type, progressive, HR-positive, HER2-negative mBC; specific regimens evaluated in VIKTORIA-1 for this patient subset 
  • Recently published efficacy and safety findings from the PIK3CA wild-type cohort of VIKTORIA-1; comparative benefit of the triplet combination (gedatolisib with fulvestrant and palbociclib) and doublet combination (gedatolisib with fulvestrant) versus fulvestrant monotherapy 
  • FDA approval of gedatolisib-containing combination therapy for pretreated HR-positive, HER2-negative mBC that is PIK3CA wild-type 

Module 4: Tolerability Considerations with PI3K/AKT/mTOR Inhibitors 

  • Spectrum of common and agent-specific adverse events (AEs) documented with PI3K/AKT/mTOR inhibitors in mBC; comparative tolerability/toxicity profiles of the various agents 
  • Pathophysiology of hyperglycemia associated with PI3K/AKT/mTOR inhibitors; incidence, severity and timing of hyperglycemia with the various agents 
  • Optimal mitigation, monitoring and management protocols for PI3K/AKT/mTOR inhibitor-associated hyperglycemia 
  • Frequency and severity of GI and cutaneous toxicities with PI3K/AKT/mTOR inhibitors; strategies to prevent and ameliorate these AEs 
  • Impact on the tolerability of PI3K/AKT/mTOR inhibitors when administered in combination with endocrine therapy or CDK4/6 inhibitors; recommendations for monitoring and management of cytopenias with combination regimens 
  • Relative and absolute contraindications to the use of and other practical considerations with PI3K/AKT/mTOR inhibitors for mBC 

Target Audience
This activity is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

Learning Objectives
Upon completion of this activity, participants should be able to

  • Review available research findings documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC). 
  • Recognize the frequency of PI3K/AKT/PTEN alterations in individuals with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations for appropriate patients with newly diagnosed and relapsed/refractory disease. 
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available and emerging data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC. 
  • Appreciate the clinical and biological factors that guide the selection and sequencing of therapy for HR-positive mBC, and use this information to personalize treatment recommendations. 
  • Recognize adverse events associated with available and investigational PI3K/AKT/mTOR inhibitors, and implement approaches to educate patients and manage complications. 
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the future role of these strategies. 

CE Credit
CME credit information will be given to each participant as part of the meeting course materials.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Privacy Policy
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Faculty disclosures to be announced.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Hurvitz — Advisory Committees: Akari Therapeutics, BeOne, Boundless Bio, BriaCell, BridgeBio, Bristol Myers Squibb, Daiichi Sankyo Inc, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Luminate, Mersana Therapeutics Inc, Novartis, Prelude Therapeutics, Roche Laboratories Inc; Consulting Agreements: ALX Oncology, Bayer HealthCare Pharmaceuticals, BeOne, Blueprint Medicines, Ellipses Pharma, EMBioSys, Genentech, a member of the Roche Group, Jazz Pharmaceuticals Inc, Myricx Bio; Contracted Research: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Menarini Group, Novartis, Stemline Therapeutics Inc; Data and Safety Monitoring Boards/Committees: Atossa Therapeutics (paid to institution), Roche Laboratories Inc (paid to UW); Nonrelevant Financial Relationships: Alliance for Clinical Trials in Oncology Foundation, InClin, Quantum Leap Healthcare Collaborative, ROMTech (Stocks for orthopedic device for postop pts; not cancer related). Dr Jhaveri — Advisory Committees and Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BBOT, BeOne, Bicycle Therapeutics, Blueprint Medicines, ConcertAI, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Halda Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Menarini Group, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Olema Oncology, Pfizer Inc, Precede Biosciences, RayzeBio, Regor Therapeutics, Relay Therapeutics, Scorpion Therapeutics, Stemline Therapeutics Inc, Zymeworks Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, BBOT, Bicycle Therapeutics, Blueprint Medicines, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc, RayzeBio, Scorpion Therapeutics, Zymeworks Inc; Nonrelevant Financial Relationships: Breast Cancer Research Foundation, Fred’s Team, Manhasset Women’s Coalition Against Breast Cancer, National Cancer Institute (BRIMM/UG3 CA239861 Award). Prof Turner — Consultant/Advisory: AstraZeneca Pharmaceuticals LP, Exact Sciences Corporation, Genentech, a member of the Roche Group, GSK, Guardant Health, Inivata, Lilly, Novartis, Pfizer Inc, Repare Therapeutics; Research Funding: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Guardant Health, Inivata, Invitae, Labcorp, MSD, Natera Inc, Personalis, Pfizer Inc. Additional faculty to be announced.

MODERATOR
Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research — Funding to City of Hope: ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, NiKang Therapeutics, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc; Contracted Research — Funding to UCSF: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc. 

Research To Practice CME Planning Committee Members, Staff and Reviewers
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Celcuity, and Genentech, a member of the Roche Group.

San Antonio Marriott Rivercenter
101 Bowie St
San Antonio, TX 78205
Hotel Phone: (210) 223-1000

Meeting Room
To be announced.

Directions
The Marriott Rivercenter hotel is conveniently located within walking distance (1.5 blocks) of the Henry B González Convention Center, where the 2026 San Antonio Breast Cancer Symposium is taking place.

Program slides will be made available prior to the start of the session.

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Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances Involving the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

TARGET AUDIENCE
This activity is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

MODERATOR — Dr Love  is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Release date: August 2026
Expiration date: August 2027

Dr Kaklamani
Basho R et al. INAVO123: Phase 3 study of first-line inavolisib / placebo + a cyclin-dependent kinase 4/6 inhibitor + letrozole in participants with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-sensitive advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-07-27.

Fernando S et al. PIK3R1 (p85α) alterations define a targetable subset of breast cancer with broad sensitivity to PI3K and AKT inhibitors. San Antonio Breast Cancer Symposium 2025;Abstract RF4-05.

Hilz S et al. Molecular features of response to palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer as assessed from baseline circulating tumor DNA in the pivotal phase 3 INAVO120 trial. San Antonio Breast Cancer Symposium 2025;Abstract PD5-09.

Jhaveri KL et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med 2025;393(2):151-61. Abstract

Kalinsky K et al. Comparative analysis of blood- and tissue-based PIK3CA mutation detection methods in the pivotal phase 3 INAVO120 trial of palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS1-10-26.

Loibl S et al. Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2-), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial. ESMO Breast Cancer 2026;Abstract 420RO.

Neven P et al. Capivasertib (C) + ribociclib (R) + fulvestrant (F) in patients (pts) with HR-positive/HER2-negative advanced breast cancer (ABC): CAPItello-292 phase Ib. ESMO Breast Cancer 2025;Abstract 316P.

Sudhan DR et al. Mechanisms of resistance to capivasertib in combination with CDK4/6 inhibitor (CDK4/6i) plus fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC): Exploratory analysis from the phase 1b CAPItello-292 study. San Antonio Breast Cancer Symposium 2025;Abstract RF4-04.

Wesolowski R et al. Gedatolisib combined with palbociclib and letrozole in patients with no prior systemic therapy for hormone receptor-positive, HER2-negative advanced breast cancer. Clin Cancer Res 2025;31(19):4040-8. Abstract

Dr Rugo
Hurvitz SA et al. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). ASCO 2026;Abstract LBA1008.

Jhaveri KL et al. A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in PIK3CA-mutant advanced solid tumors: Updated results from PIKALO-1. ASCO 2026;Abstract 1072.

Pistilli B et al. Gedatolisib (Geda), a multitarget PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant (Fulv) ± palbociclib (Palbo) for second-line (2L) treatment of patients (Pts) with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): Updated results from VIKTORIA-1. ESMO Breast Cancer 2026;Abstract 505P.

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2- advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial. ESMO Breast Cancer 2026;Abstract 417O.

Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P.

Saura C et al. Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD. San Antonio Breast Cancer Symposium 2025;Abstract PD10-07.

Turner NC et al. Capivasertib plus fulvestrant in hormone receptor-positive (HR+) advanced breast cancer (ABC): Exploratory ctDNA analyses from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2025;Abstract RF7-05.

Vaklavas C et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: Results from SERENA-1. ESMO Open 2026;11(2):106049. Abstract

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances Involving the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

To play this presentation please log in.

Don't have an account?

Sign up for free and get access to 400+ programs, live events, CME/CNE evaluations, bookmarks, watch history, and more.

Faculty

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

TARGET AUDIENCE
This activity is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the videos, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

MODERATOR — Dr Love  is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Release date: August 2026
Expiration date: August 2027

Dr Kaklamani
Basho R et al. INAVO123: Phase 3 study of first-line inavolisib / placebo + a cyclin-dependent kinase 4/6 inhibitor + letrozole in participants with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-sensitive advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-07-27.

Fernando S et al. PIK3R1 (p85α) alterations define a targetable subset of breast cancer with broad sensitivity to PI3K and AKT inhibitors. San Antonio Breast Cancer Symposium 2025;Abstract RF4-05.

Hilz S et al. Molecular features of response to palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer as assessed from baseline circulating tumor DNA in the pivotal phase 3 INAVO120 trial. San Antonio Breast Cancer Symposium 2025;Abstract PD5-09.

Jhaveri KL et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med 2025;393(2):151-61. Abstract

Kalinsky K et al. Comparative analysis of blood- and tissue-based PIK3CA mutation detection methods in the pivotal phase 3 INAVO120 trial of palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS1-10-26.

Loibl S et al. Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2-), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial. ESMO Breast Cancer 2026;Abstract 420RO.

Neven P et al. Capivasertib (C) + ribociclib (R) + fulvestrant (F) in patients (pts) with HR-positive/HER2-negative advanced breast cancer (ABC): CAPItello-292 phase Ib. ESMO Breast Cancer 2025;Abstract 316P.

Sudhan DR et al. Mechanisms of resistance to capivasertib in combination with CDK4/6 inhibitor (CDK4/6i) plus fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC): Exploratory analysis from the phase 1b CAPItello-292 study. San Antonio Breast Cancer Symposium 2025;Abstract RF4-04.

Wesolowski R et al. Gedatolisib combined with palbociclib and letrozole in patients with no prior systemic therapy for hormone receptor-positive, HER2-negative advanced breast cancer. Clin Cancer Res 2025;31(19):4040-8. Abstract

Dr Rugo
Hurvitz SA et al. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). ASCO 2026;Abstract LBA1008.

Jhaveri KL et al. A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in PIK3CA-mutant advanced solid tumors: Updated results from PIKALO-1. ASCO 2026;Abstract 1072.

Pistilli B et al. Gedatolisib (Geda), a multitarget PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant (Fulv) ± palbociclib (Palbo) for second-line (2L) treatment of patients (Pts) with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): Updated results from VIKTORIA-1. ESMO Breast Cancer 2026;Abstract 505P.

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2- advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial. ESMO Breast Cancer 2026;Abstract 417O.

Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P.

Saura C et al. Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD. San Antonio Breast Cancer Symposium 2025;Abstract PD10-07.

Turner NC et al. Capivasertib plus fulvestrant in hormone receptor-positive (HR+) advanced breast cancer (ABC): Exploratory ctDNA analyses from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2025;Abstract RF7-05.

Vaklavas C et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: Results from SERENA-1. ESMO Open 2026;11(2):106049. Abstract

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances Involving the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2027

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Faculty

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

TARGET AUDIENCE
This activity is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the videos, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

MODERATOR — Dr Love  is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Release date: August 2026
Expiration date: August 2027

Dr Kaklamani
Basho R et al. INAVO123: Phase 3 study of first-line inavolisib / placebo + a cyclin-dependent kinase 4/6 inhibitor + letrozole in participants with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-sensitive advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-07-27.

Fernando S et al. PIK3R1 (p85α) alterations define a targetable subset of breast cancer with broad sensitivity to PI3K and AKT inhibitors. San Antonio Breast Cancer Symposium 2025;Abstract RF4-05.

Hilz S et al. Molecular features of response to palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer as assessed from baseline circulating tumor DNA in the pivotal phase 3 INAVO120 trial. San Antonio Breast Cancer Symposium 2025;Abstract PD5-09.

Jhaveri KL et al. Overall survival with inavolisib in PIK3CA-mutated advanced breast cancer. N Engl J Med 2025;393(2):151-61. Abstract

Kalinsky K et al. Comparative analysis of blood- and tissue-based PIK3CA mutation detection methods in the pivotal phase 3 INAVO120 trial of palbociclib + fulvestrant ± inavolisib in hormone receptor-positive, HER2-negative advanced breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS1-10-26.

Loibl S et al. Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2-), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial. ESMO Breast Cancer 2026;Abstract 420RO.

Neven P et al. Capivasertib (C) + ribociclib (R) + fulvestrant (F) in patients (pts) with HR-positive/HER2-negative advanced breast cancer (ABC): CAPItello-292 phase Ib. ESMO Breast Cancer 2025;Abstract 316P.

Sudhan DR et al. Mechanisms of resistance to capivasertib in combination with CDK4/6 inhibitor (CDK4/6i) plus fulvestrant in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC): Exploratory analysis from the phase 1b CAPItello-292 study. San Antonio Breast Cancer Symposium 2025;Abstract RF4-04.

Wesolowski R et al. Gedatolisib combined with palbociclib and letrozole in patients with no prior systemic therapy for hormone receptor-positive, HER2-negative advanced breast cancer. Clin Cancer Res 2025;31(19):4040-8. Abstract

Dr Rugo
Hurvitz SA et al. A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant (MT) advanced breast cancer (VIKTORIA-1 Study 2). ASCO 2026;Abstract LBA1008.

Jhaveri KL et al. A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in PIK3CA-mutant advanced solid tumors: Updated results from PIKALO-1. ASCO 2026;Abstract 1072.

Pistilli B et al. Gedatolisib (Geda), a multitarget PI3K/AKT/mTOR (PAM) inhibitor, plus fulvestrant (Fulv) ± palbociclib (Palbo) for second-line (2L) treatment of patients (Pts) with HR+/HER2-/PIK3CA-wild type (WT) advanced breast cancer (ABC): Updated results from VIKTORIA-1. ESMO Breast Cancer 2026;Abstract 505P.

Rugo HS et al. Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2- advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial. ESMO Breast Cancer 2026;Abstract 417O.

Rugo HS et al. Capivasertib plus fulvestrant as first and second-line endocrine-based therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the phase 3 CAPItello-291 trial. ESMO 2025;Abstract 526P.

Saura C et al. Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD. San Antonio Breast Cancer Symposium 2025;Abstract PD10-07.

Turner NC et al. Capivasertib plus fulvestrant in hormone receptor-positive (HR+) advanced breast cancer (ABC): Exploratory ctDNA analyses from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2025;Abstract RF7-05.

Vaklavas C et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: Results from SERENA-1. ESMO Open 2026;11(2):106049. Abstract

Addressing Community Oncologists’ Questions About the Current and Future Role of Antibody-Drug Conjugates in the Management of Breast Cancer

Accreditation types: 2.25 ABIM MOC, ABS MOC, CME

Expires: July 2027

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Faculty

Professor Giuseppe Curigliano

Faculty

Professor Giuseppe Curigliano

MD, PhD

University of Milano, European Institute of Oncology, Milano, Italy

Clinical Director, Division of Early Drug Development for Innovative Therapy, Co-Chair, Cancer Experimental Therapeutics Program, Department of Oncology and Hemato-Oncology

Rebecca A Dent

Faculty

Rebecca A Dent

MD, MSc

National Cancer Centre Singapore, Singapore

Senior Consultant, Division of Medical Oncology

Duke-NUS Medical School, Singapore

Professor

Erika Hamilton

Faculty

Erika Hamilton

MD

Sarah Cannon Research Institute, SCRI Oncology Partners, Nashville, Tennessee

Chief Development Officer, Late Phase, Director, Breast Cancer Research Program

Hope S Rugo

Moderator

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

Nadia Harbeck

Faculty

Nadia Harbeck

MD, PhD

LMU University Hospital, Munich, Germany

Breast Center Director, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, hematologists, hematology-oncology fellows, general and breast surgeons and other healthcare providers involved in the treatment of breast cancer.

LEARNING OBJECTIVES

  • Assess available Phase III data with HER2-directed antibody-drug conjugate (ADC) therapy as a component of neoadjuvant therapy for patients with high-risk localized breast cancer, and consider the current clinical role of this novel treatment approach.
  • Evaluate current research evidence with HER2-directed ADC therapy for patients with HER2-positive localized breast cancer and residual disease after neoadjuvant treatment.
  • Appraise available research data and relevant clinical and biological factors guiding the selection of first-line therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC).
  • Review published research supporting TROP2-directed ADC therapy in combination with anti-PD-1/PD-L1 antibodies for triple-negative mBC, and use this information to make appropriate treatment recommendations.
  • Evaluate published clinical research findings with TROP2-directed ADC monotherapy for HR-positive and triple-negative mBC, and optimally incorporate these agents into clinical care.
  • Assess the biological rationale for the evaluation of HER2-directed ADCs for HER2-low and HER2-ultralow mBC, and identify patients appropriate for this treatment approach.
  • Discern the side effects and toxicities associated with FDA-approved ADCs in the care of patients with breast cancer, and identify strategies to manage and mitigate these complications.
  • Recall ongoing trials evaluating the potential role of novel ADC-based strategies in the localized and metastatic settings, and appropriately counsel patients with breast cancer regarding enrollment.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 2.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Prof Curigliano — Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Roche Laboratories Inc. Prof Dent — Advisory Committees and Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Lilly, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Roche Laboratories Inc. Dr Hamilton — Consulting/Advisory Roles (All Payments to Institution): Accutar Biotechnology Inc, Arvinas, AstraZeneca Pharmaceuticals LP, BeOne, Circle Pharma, Daiichi Sankyo Inc, Entos Pharmaceuticals, Genentech, a member of the Roche Group, Gilead Sciences Inc, Halda Therapeutics, Incyclix Bio, IQVIA, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Jefferies LLC, Johnson & Johnson, Lilly, Medical Pharma Services SRO, Mersana Therapeutics Inc, Novartis, Pfizer Inc, Pyxis Oncology, Samsung Bioepis, Shorla Oncology, Stemline Therapeutics Inc, Tempus, Zentalis Pharmaceuticals; Research Funding (All Payments to Institution): AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Accutar Biotechnology Inc, ADC Therapeutics, Akesobio Australia Pty Ltd, Amgen Inc, Aravive Inc, ARS Pharmaceuticals, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP, AtlasMedx Inc, BeOne, Black Diamond Therapeutics Inc, Bliss Biopharmaceutical (Hangzhou) Co Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Compugen, Context Therapeutics, Cullinan Therapeutics, Curis Inc, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Deciphera Pharmaceuticals Inc, Duality Biologics, eFFECTOR Therapeutics Inc, Eisai Inc, Ellipses Pharma, Elucida Oncology Inc, EMD Serono Inc, Fochon Pharmaceuticals, FUJIFILM Pharmaceuticals USA Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Harpoon Therapeutics, Hutchison MediPharma, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Inspirna, InventisBio, Jacobio Pharmaceuticals Group Co Ltd, Karyopharm Therapeutics, K-Group Beta, Kind Pharmaceuticals LLC, Leap Therapeutics Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Lycera, MacroGenics Inc, Marker Therapeutics Inc, Merck, Mereo BioPharma, Mersana Therapeutics Inc, Merus, Molecular Templates, Myriad Genetic Laboratories Inc, Novartis, NuCana, Olema Oncology, Oncothyreon, ORIC Pharmaceuticals, Orinove Inc, Orum Therapeutics, Pfizer Inc, pharmaand GmbH, PharmaMar, Pieris Pharmaceuticals Inc, Pionyr Immunotherapeutics, Plexxikon Inc, Prelude Therapeutics, ProFound Therapeutics, Radius Health Inc, Regeneron Pharmaceuticals Inc, Relay Therapeutics, Repertoire Immune Medicines, Seagen Inc, Sermonix Pharmaceuticals, Shattuck Labs, Stemline Therapeutics Inc, Sutro Biopharma, Syndax Pharmaceuticals, Syros Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Tesaro, A GSK Company, Tolmar, Transcenta, Treadwell Therapeutics, Verastem Inc, Zenith Epigenetics, Zymeworks Inc; Nonrelevant Financial Relationships: Dana-Farber Cancer Institute. Prof Harbeck — Consulting Agreements: Exact Sciences Corporation, Sandoz Inc, a Novartis Division; Data and Safety Monitoring Boards/Committees: Gilead Sciences Inc, IQVIA, Roche Laboratories Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, MSD, Novartis, Pfizer Inc, Pierre Fabre, Roche Laboratories Inc, Stemline Therapeutics Inc, Viatris, Zuellig Pharma; Nonrelevant Financial Relationships: West German Study Group (WSG).

MODERATOR

Dr Rugo — Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Merck, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Release date: July 2026
Expiration date: July 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Prof Dent

Cameron DAA et al. DESTINY-Breast04 subgroup analyses of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with human epidermal growth factor 2 (HER2)-low, estrogen-receptor (ER) expression immunohistochemistry (IHC) 0-10% metastatic breast cancer (mBC). ESMO Breast 2023;Abstract 192MO.

Cortes JC et al. Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i). ESMO 2025;Abstract LBA20.

Cortés J et al. Sacituzumab govitecan in untreated, advanced triple-negative breast cancer. N Engl J Med 2025;393(19):1912-25. Abstract

de Azambuja E et al. Metastatic breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol 2026;[Online ahead of print]. Abstract

Dent R et al. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): A randomised, open-label, international, phase III trial. Ann Oncol 2026;[Online ahead of print]. Abstract

Dent R et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial. ESMO 2025;Abstract LBA21.

Dent R et al. IMpassion132 double-blind randomised phase III trial of chemotherapy with or without atezolizumab for early relapsing unresectable locally advanced or metastatic triple-negative breast cancer. Ann Oncol 2024;35(7):630-62. Abstract

Garrido-Castro AC et al. TROP2-directed antibody drug conjugates: New first-line treatment for all patients with advanced triple-negative breast cancer? Ann Oncol 2026;[Online ahead of print]. Abstract

Medford A et al. Antibody drug conjugates for patients with breast cancer. Curr Probl Cancer 2021;45(5):100795. Abstract

Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med 2022;387(1):9-20. Abstract

Schmid P et al. Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: Results from arms 7 and 8 of the phase Ib/II BEGONIA study. Ann Oncol 2026[Online ahead of print]. Abstract

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2026;394(6):551-62. Abstract

Tolaney SM et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. ASCO 2025;Abstract LBA109.

Zhang J et al. Pumitamig in combination with DB-1305/BNT325 as first-line (1L) treatment for patients with advanced or metastatic triple-negative breast cancer (a/mTNBC): Efficacy and safety from a multicenter, open-label, phase I/II trial. ESMO Breast 2026;Abstract 426RO.

Prof Curigliano

Bartsch R et al. Final outcome analysis from the phase II TUXEDO-1 trial of trastuzumab-deruxtecan in HER2-positive breast cancer patients with active brain metastases. Neuro Oncol 2024;26(12):2305-15. Abstract

Dieras V et al. HER2CLIMB-05: A phase III study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer. J Clin Oncol 2026;44(17):1597-607. Abstract

Hurvitz SA et al. A pooled analysis of trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with brain metastases (BMs) from DESTINY-Breast (DB) -01, -02, and -03. ESMO 2023;Abstract 377O.

Lin N et al. Trastuzumab deruxtecan in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: DESTINY-Breast12 primary results. ESMO 2024;Abstract LBA18.

Metzger O et al. Palbociclib for hormone-receptor-positive, HER2-positive advanced breast cancer. N Engl J Med 2026;394(5):451-62. Abstract

Song E et al. SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01). ESMO 2025;Abstract LBA19.

Swain SM et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): End-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol 2020;21(4):519-30. Abstract

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2026;394(6):551-62. Abstract

Vaz Batista M et al. Trastuzumab deruxtecan in patients with HER2[+] or HER2-low advanced breast cancer and pathologically confirmed leptomeningeal carcinomatosis: Results from cohort 5 of the DEBBRAH study. San Antonio Breast Cancer Symposium 2023;Abstract PS11-05.

Dr Rugo

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Bardia A et al. Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: Additional analysis from DESTINY-Breast06. San Antonio Breast Cancer Symposium 2024;Abstract LB1-04.

Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract

Bardia A et al. Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01. San Antonio Breast Cancer Symposium 2023;Abstract GS02-01.

Curigliano G et al. Trastuzumab deruxtecan in hormone receptor-positive, HER2-low/-ultralow metastatic breast cancer (DESTINY-Breast06): Outcome analyses by time to progression on prior first-line endocrine therapy with CDK4/6 inhibitor and baseline burden of disease. Ann Oncol 2026;37(6):849-60. Abstract

Curigliano G et al. Trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): Primary results from DESTINY-Breast06 (DB-06). ASCO 2024;Abstract LBA1000.

Hamilton EP et al. A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with metastatic breast cancer (MBC). ESMO Breast 2026;Abstract 422RO.

Jhaveri KL et al. Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07. San Antonio Breast Cancer Symposium 2025;Abstract GS1-09.

Modi S et al. Trastuzumab deruxtecan in HER2-low metastatic breast cancer: Long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial. Nat Med 2025;31(12):4205-13. Abstract

Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Updated survival results of the randomized, phase III DESTINY-Breast04 study. ESMO 2023;Abstract 376O.

Pistilli B et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: Final overall survival analysis of the phase III TROPION-Breast01 study. Ann Oncol 2026;37(5):663-74. Abstract

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Rugo HS et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): A randomised, open-label, multicentre, phase 3 trial. Lancet 2023;402(10411):1423-33. Abstract

Rugo HS et al. Overall survival (OS) results from the phase III TROPiCS-02 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with HR+/HER2- metastatic breast cancer (mBC). ESMO 2022;Abstract LBA76.

Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2022;40(29):3365-76. Abstract

Tolaney SM et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). ASCO 2023;Abstract 1003.

Prof Harbeck

Cortazar P et al. Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet 2014;384(9938):164-72. Abstract

Geyer CE et al. Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05. ESMO 2025;Abstract LBA1.

Harbeck N et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): A randomised, open-label, multicentre, phase III trial. Ann Oncol 2026;37(2):166-79. Abstract

Harbeck N et al. DESTINY-Breast11: Neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC). ESMO 2025;Abstract 291O.

Harbeck N et al. Trofuse-032: A phase 3, randomized study of pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer or hormone receptor-low-positive (HR-low+)/ human epidermal growth factor receptor 2-negative (HER2−) breast cancer. San Antonio Breast Cancer Symposium 2025;Abstract PS5-12-25.

Loibl S et al. Trastuzumab deruxtecan in residual HER2-positive early breast cancer. N Engl J Med 2026;394(9):845-57. Abstract

Loibl S et al. Early breast cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol 2024;35(2):159-82. Abstract

Loibl S et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. San Antonio Breast Cancer Symposium 2023;Abstract GS03-12.

McArthur HL et al. TROPION-Breast04: A randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients with treatment-naïve early-stage triple negative or HR-low/HER2- breast cancer. Ther Adv Med Oncol 2025;17:17588359251316176. Abstract

Dr Hamilton

Ciruelos E et al. Safety profile of trastuzumab deruxtecan in advanced breast cancer: Expert opinion on adverse event management. Clin Transl Oncol 2024;26(7):1539-48. Abstract

Kang S, Kim SB. Toxicities and management strategies of emerging antibody-drug conjugates in breast cancer. Ther Adv Med Oncol 2025;17:17588359251324889. Abstract

Meric-Bernstam F et al. Prophylaxis, clinical management, and monitoring of datopotamab deruxtecan-associated oral mucositis/stomatitis. Oncologist 2025;30(3). Abstract

Riccardi F et al. A comprehensive overview on antibody-drug conjugates: From the conceptualization to cancer therapy. Front Pharmacol 2023;14:1274088. Abstract

Rugo HS et al. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open 2022;7(4):100553. Abstract

Tarantino P, Tolaney SM. Detecting and managing T-DXd-related interstitial lung disease: The five “S” rules. JCO Oncol Pract 2023;19(8):526-7. Abstract

PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

Year in Review: Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Oncology

A Multitumor CME/MOC-Accredited Live Webinar Series

Wednesday, July 15, 2026
5:00 PM – 6:00 PM ET
Live CME/MOC-accredited webinar

Virginia Kaklamani

Faculty

Virginia Kaklamani

MD, DSc

UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas

Professor of Medicine, Ruth McLean Bowman Bowers Chair in Breast Cancer Research and Treatment, AB Alexander Distinguished Chair in Oncology, Leader, Breast Oncology Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

University of California, San Francisco

Professor Emeritus

Neil Love

Moderator

Neil Love

MD

Research To Practice

Miami, Florida

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

Wednesday, July 15, 2026
5:00 PM – 6:00 PM ET
Live CME/MOC-accredited webinar

Topics to Be Discussed

  • Identification of Appropriate Candidates with Hormone Receptor (HR-Positive) Metastatic Breast Cancer (mBC) for Agents Targeting the PI3K/AKT/mTOR Pathway; Role in the Up-Front Setting
  • Clinical Utility of Agents Targeting the PI3K/AKT/mTOR Pathway for Patients with Progressive HR-Positive mBC

Target Audience
This activity is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

Learning Objectives
Upon completion of this activity, participants should be able to

  • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies, and develop optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations in patients with HR-positive mBC, and employ evidence-based approaches designed to target these aberrations as appropriate for those with newly diagnosed and relapsed/refractory disease.
  • Understand the biological rationale for the development of agents targeting multiple components of the PI3K/AKT/mTOR pathway, and recognize available data with this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies in clinical practice.

CE Credit
CME and ABIM MOC credit information will be provided to each participant at the conclusion of the activity.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC) 
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for this activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. 

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology. 

American Board of Surgery (ABS) — Continuous Certification (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn up to 1 Medical Knowledge MOC point toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

Privacy Policy
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. 

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:
Dr Kaklamani — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc. Dr Rugo — Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research: Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Research Funding (to Institution): ALX Oncology, Bicycle Therapeutics, Genentech, a member of the Roche Group, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Phoenix Molecular Designs, Relay Therapeutics, Stemline Therapeutics Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Celcuity.

This event has passed.

What Clinicians Want to Know: Addressing Community Oncologists’ Questions About the Current and Future Role of Antibody-Drug Conjugates in the Management of Breast Cancer

A CME Symposium Held Adjunct with the 2026 ASCO® Annual Meeting

Location
Hilton Chicago
720 South Michigan Avenue
Chicago, Illinois
Phone: (312) 922-4400

Program Schedule — Central Time
6:30 PM – 7:00 PM — Registration and Dinner
7:00 PM – 9:00 PM — Educational Meeting

Meeting Room
Continental Room A (Lobby Level)

No registration fee is charged for this event. For the in-person symposium in Chicago, preregistration is required as seating is limited.

Faculty

Professor Giuseppe Curigliano

Faculty

Professor Giuseppe Curigliano

MD, PhD

University of Milano European Institute of Oncology, Milano, Italy

Clinical Director, Division of Early Drug Development for Innovative Therapy, Co-Chair, Cancer Experimental Therapeutics Program, Department of Oncology and Hemato-Oncology

Rebecca A Dent

Faculty

Rebecca A Dent

MD, MSc

National Cancer Centre Singapore, Singapore

Senior Consultant, Division of Medical Oncology

Duke-NUS Medical School, Singapore

Professor

Erika Hamilton

Faculty

Erika Hamilton

MD

Sarah Cannon Research Institute, SCRI Oncology Partners, Nashville, Tennessee

Chief Development Officer, Late Phase, Director, Breast Cancer Research Program

Hope S Rugo

Moderator

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

UCSF

Professor Emeritus

Nadia Harbeck

Faculty

Nadia Harbeck

MD, PhD

LMU University Hospital, Munich, Germany

Breast Center Director, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Not an official event of the 2026 ASCO® Annual Meeting. Not sponsored, endorsed, or accredited by ASCO®, Association for Clinical Oncology, or Conquer Cancer®, the ASCO Foundation.

Program Schedule — Central Time
6:30 PM – 7:00 PM — Registration and Dinner
7:00 PM – 9:00 PM — Educational Meeting

MODULE 1: Evolving Role of Antibody-Drug Conjugates (ADCs) in the Management of Metastatic Triple-Negative Breast Cancer (mTNBC)

  • Scientific rationale for investigating TROP2-directed ADCs for previously untreated mTNBC
  • Key efficacy and safety data from the Phase III ASCENT-04/KEYNOTE-D19 and ASCENT-03 trials evaluating sacituzumab govitecan in combination with pembrolizumab and as monotherapy for patients with previously untreated PD-L1-positive and PD-L1-negative mTNBC, respectively
  • Published data from the Phase III TROPION-Breast02 study of first-line datopotamab deruxtecan (Dato-DXd) versus chemotherapy for patients with advanced TNBC for whom immunotherapy was not an option
  • Recent FDA approval of Dato-DXd for patients with previously untreated mTNBC who are not candidates for PD-1/PD-L1 inhibitor therapy; current clinical utility of this strategy and potential role of sacituzumab govitecan in the up-front setting 
  • Updated data with trastuzumab deruxtecan (T-DXd) in the subset of patients with previously treated hormone receptor (HR)-negative, HER2-low advanced breast cancer in the Phase III DESTINY-Breast04 study; current role alongside other treatment options
  • Clinical trial findings with and ongoing investigation of other ADCs for mTNBC, such as sacituzumab tirumotecan and izalontamab brengitecan

MODULE 2: Integrating ADCs into the Management of HER2-Positive Metastatic Breast Cancer (mBC)

  • Historical outcomes with standard HER2-targeted therapies for newly diagnosed HER2-positive mBC; rationale for the evaluation of HER2-targeted ADCs in the front-line setting
  • Published efficacy and safety findings from the Phase III DESTINY-Breast09 trial documenting the benefit of T-DXd/pertuzumab versus taxane/trastuzumab/pertuzumab as first-line therapy for HER2-positive mBC
  • Implications of the DESTINY-Breast09 trial for sequencing therapies for HER2-positive mBC
  • Intracranial efficacy documented with T-DXd in published clinical trials, including DESTINY-Breast01, 02 and 03, DESTINY-Breast12, DEBBRAH and TUXEDO-1; implications for the management of HER2-positive mBC
  • Outcomes documented among patients with previously treated HER2-positive mBC without CNS involvement in pivotal clinical studies of T-DXd
  • Other promising HER2-directed ADCs under investigation for HER2-positive mBC

MODULE 3: Role of ADCs in the Management of Endocrine-Resistant HR-Positive mBC

  • Long-term efficacy and safety findings from the Phase III TROPiCS-02 trial of sacituzumab govitecan for previously treated HR-positive, HER2-negative mBC
  • Optimal integration of sacituzumab govitecan into management algorithms for HR-positive, HER2-negative disease
  • Available efficacy and safety findings from the Phase III TROPION-Breast01 study of Dato-DXd versus investigator’s choice of chemotherapy for pretreated HR-positive, HER2-negative mBC
  • FDA approval of Dato-DXd for patients with HR-positive, HER2-negative mBC who have previously received endocrine-based therapy and chemotherapy; current clinical role
  • Available data from the DESTINY-Breast04 and DESTINY-Breast06 studies evaluating T-DXd versus chemotherapy for patients with previously treated HER2-low and HER2-ultralow advanced breast cancer
  • FDA approval of T-DXd for advanced HR-positive, HER2-low and HER2-ultralow breast cancer progressing after one or more endocrine therapies in the metastatic setting; optimal incorporation into disease management

MODULE 4: Utility of ADCs for Localized Breast Cancer

  • Key clinical factors in the selection of neoadjuvant and adjuvant systemic therapy for patients with HER2-positive localized breast cancer; effect of various therapeutic approaches on outcomes
  • Published findings from the Phase III DESTINY-Breast11 study evaluating T-DXd as a component of neoadjuvant therapy for patients with high-risk, HER2-positive localized breast cancer
  • Recently presented data from the Phase III DESTINY-Breast05 study of T-DXd versus T-DM1 for patients with high-risk HER2-positive breast cancer and residual invasive disease after neoadjuvant therapy
  • Recent FDA approval of T-DXd in the neoadjuvant and adjuvant settings; selection of appropriate candidates with HER2-positive localized breast cancer for these strategies 
  • Ongoing Phase III trials, such as ASCENT-05, ADAPT-TN-III, ADAPT-TN-IV, TROPION-Breast04, TROPION-Breast05, TroFuse-012 and TroFuse-032, evaluating TROP2 ADCs as a component of neoadjuvant or adjuvant therapy for localized disease; estimated completion dates

MODULE 5: Tolerability Considerations with ADCs for Breast Cancer

  • Spectrum, incidence and severity of common and unique adverse events (AEs) with different ADCs employed in the management of breast cancer
  • Monitoring and management of acute “chemotherapy-like” AEs reported with ADCs, such as cytopenias and gastrointestinal events
  • Recommended algorithms for mitigating more serious (eg, interstitial lung disease, left ventricular dysfunction) or unique (eg, oral mucositis/stomatitis, ocular AEs) toxicities documented with one or more ADCs
  • Strategies to distinguish the cause of AEs that could be attributable to either agent in ADC-containing combination regimens
  • Impact on tolerability, if any, of the placement of ADCs in the treatment course (eg, later-line therapy for metastatic disease, first-line therapy for metastatic disease or neoadjuvant/adjuvant therapy)

Target Audience
This activity is intended for medical and radiation oncologists, hematologists, hematology-oncology fellows, general and breast surgeons and other healthcare providers involved in the treatment of breast cancer.

Learning Objectives
At the conclusion of this activity, participants should be able to

  • Assess available Phase III data with HER2-directed antibody-drug conjugate (ADC) therapy as a component of neoadjuvant therapy for patients with high-risk localized breast cancer, and consider the current clinical role of this novel treatment approach.
  • Evaluate current research evidence with HER2-directed ADC therapy for patients with HER2-positive localized breast cancer and residual disease after neoadjuvant treatment.
  • Appraise available research data and relevant clinical and biological factors guiding the selection of first-line therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC).
  • Review published research supporting TROP2-directed ADC therapy in combination with anti-PD-1/PD-L1 antibodies for triple-negative mBC, and use this information to make appropriate treatment recommendations.
  • Evaluate published clinical research findings with TROP2-directed ADC monotherapy for HR-positive and triple-negative mBC, and optimally incorporate these agents into clinical care.
  • Assess the biological rationale for the evaluation of HER2-directed ADCs for HER2-low and HER2-ultralow mBC, and identify patients appropriate for this treatment approach.
  • Discern the side effects and toxicities associated with FDA-approved ADCs in the care of patients with breast cancer, and identify strategies to manage and mitigate these complications.
  • Recall ongoing trials evaluating the potential role of novel ADC-based strategies in the localized and metastatic settings, and appropriately counsel patients with breast cancer regarding enrollment.

CME Credit Form
A CME credit link will be given to each participant as part of the meeting course materials.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Privacy Policy
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. 

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Prof Curigliano — Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Roche Laboratories Inc. Prof Dent — Advisory Committees and Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Lilly, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Roche Laboratories Inc. Dr Hamilton — Consulting/Advisory Roles (All Payments to Institution): Accutar Biotechnology Inc, Arvinas, AstraZeneca Pharmaceuticals LP, BeOne, Circle Pharma, Daiichi Sankyo Inc, Entos Pharmaceuticals, Genentech, a member of the Roche Group, Gilead Sciences Inc, Halda Therapeutics, Incyclix Bio, IQVIA, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Jefferies LLC, Johnson & Johnson, Lilly, Medical Pharma Services SRO, Mersana Therapeutics Inc, Novartis, Pfizer Inc, Pyxis Oncology, Samsung Bioepis, Shorla Oncology, Stemline Therapeutics Inc, Tempus, Zentalis Pharmaceuticals; Research Funding (All Payments to Institution): AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Accutar Biotechnology Inc, ADC Therapeutics, Akesobio Australia Pty Ltd, Amgen Inc, Aravive Inc, ARS Pharmaceuticals, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP, AtlasMedx Inc, BeOne, Black Diamond Therapeutics Inc, Bliss Biopharmaceutical (Hangzhou) Co Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Compugen, Context Therapeutics, Cullinan Therapeutics, Curis Inc, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Deciphera Pharmaceuticals Inc, Duality Biologics, eFFECTOR Therapeutics Inc, Eisai Inc, Ellipses Pharma, Elucida Oncology Inc, EMD Serono Inc, Fochon Pharmaceuticals, FUJIFILM Pharmaceuticals USA Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Harpoon Therapeutics, Hutchison MediPharma, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Inspirna, InventisBio, Jacobio Pharmaceuticals Group Co Ltd, Karyopharm Therapeutics, K-Group Beta, Kind Pharmaceuticals LLC, Leap Therapeutics Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Lycera, MacroGenics Inc, Marker Therapeutics Inc, Merck, Mereo BioPharma, Mersana Therapeutics Inc, Merus, Molecular Templates, Myriad Genetic Laboratories Inc, Novartis, NuCana, Olema Oncology, Oncothyreon, ORIC Pharmaceuticals, Orinove Inc, Orum Therapeutics, Pfizer Inc, pharmaand GmbH, PharmaMar, Pieris Pharmaceuticals Inc, Pionyr Immunotherapeutics, Plexxikon Inc, Prelude Therapeutics, ProFound Therapeutics, Radius Health Inc, Regeneron Pharmaceuticals Inc, Relay Therapeutics, Repertoire Immune Medicines, Seagen Inc, Sermonix Pharmaceuticals, Shattuck Labs, Stemline Therapeutics Inc, Sutro Biopharma, Syndax Pharmaceuticals, Syros Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Tesaro, A GSK Company, Tolmar, Transcenta, Treadwell Therapeutics, Verastem Inc, Zenith Epigenetics, Zymeworks Inc; Nonrelevant Financial Relationships: Dana-Farber Cancer Institute. Prof Harbeck — Consulting Agreements: Exact Sciences Corporation, Sandoz Inc, a Novartis Division; Data and Safety Monitoring Boards/Committees: Gilead Sciences Inc, IQVIA, Roche Laboratories Inc; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, MSD, Novartis, Pfizer Inc, Pierre Fabre, Roche Laboratories Inc, Stemline Therapeutics Inc, Viatris, Zuellig Pharma; Nonrelevant Financial Relationships: West German Study Group (WSG).

MODERATOR
Dr Rugo — Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Merck, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc.

Hilton Chicago
720 South Michigan Avenue
Chicago, IL 60605
Phone: (312) 922-4400

Meeting Room
Continental Room A (Lobby Level)

Directions
The Hilton Chicago hotel is located just 5 minutes (2.5 miles) north of the McCormick Place convention center, where the ASCO Annual Meeting is taking place.

Register for webinar

Thank you for your interest in our CME program taking place in Chicago. Online registration for in-person attendance is now closed for this event. Seats are still available for the program and will be offered on a first come, first served basis.

Our onsite registration desk will open at 6:30 PM on Monday, June 1st. If you are interested in attending, please visit the registration desk outside Continental Room A (Lobby Level) at the Hilton Chicago hotel (720 South Michigan Avenue, Chicago, IL 60605).

Please note that onsite registration does not guarantee seating or participation in the meal service, which will be based on availability.

If you have any questions, please contact us at Meetings@ResearchToPractice.com or (800) 233-6153.

Diabetology for the Medical Oncologist: Managing Hyperglycemia in Patients with Breast Cancer Receiving Agents Targeting the PI3K/AKT/PTEN Pathway

Accreditation types: 1.5 ABIM MOC, ABS MOC, CME

Expires: March 2027

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Faculty

Jamie Carroll

Faculty

Jamie Carroll

APRN, MSN, CNP

Mayo Clinic, Rochester, Minnesota

Assistant Professor, Oncology

Professor Giuseppe Curigliano

Faculty

Professor Giuseppe Curigliano

MD, PhD

University of Milano European Institute of Oncology, Milano, Italy

Clinical Director, Division of Early Drug Development for Innovative Therapy, Co-Chair, Cancer Experimental Therapeutics Program, Department of Oncology and Hemato-Oncology

Marie E McDonnell

Faculty

Marie E McDonnell

MD

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

Brigham and Women’s Hospital, Boston, Massachusetts

Director, Diabetes Program

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

UCSF

Professor Emeritus

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Evaluate relevant biological, patient and treatment-related factors to personalize the selection and sequencing of therapy for individuals diagnosed with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer (mBC) harboring PI3K/AKT/PTEN pathway abnormalities.
  • Appreciate the pathophysiology, frequency and severity of hyperglycemia associated with the administration of various agents targeting the PI3K/AKT/PTEN pathway in HR-positive, HER2-negative mBC.
  • Recall strategies commonly employed to mitigate and manage hyperglycemia in individuals receiving treatment with agents targeting the PI3K/AKT/PTEN pathway, and use this information to appropriately intervene when this side effect is suspected or diagnosed.
  • Appraise the role of multidisciplinary specialists such as endocrinologists in the diagnosis and management of hyperglycemia associated with agents targeting the PI3K/AKT/PTEN pathway, and effectively collaborate with these clinicians to offer best-practice care for patients at high risk for or with a suspected or confirmed diagnosis of this toxicity.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.5 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Proceedings: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/DiabetologyERPosmBC2026/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Jamie Carroll, APRN, MSN, CNP
Assistant Professor, Oncology
Mayo Clinic
Rochester, Minnesota

Consulting Agreements: AstraZeneca Pharmaceuticals LP, Lilly, Novartis.

Professor Giuseppe Curigliano, MD, PhD
Clinical Director
Division of Early Drug Development for Innovative Therapy
Co-Chair, Cancer Experimental Therapeutics Program
Department of Oncology and Hemato-Oncology
University of Milano
European Institute of Oncology
Milano, Italy

Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Roche Laboratories Inc.

Marie E McDonnell, MD
Associate Professor of Medicine
Harvard Medical School
Director, Diabetes Program
Brigham and Women’s Hospital
Boston, Massachusetts

Contracted Research: Abbott.

Hope S Rugo, MD
Director, Women’s Cancers Program
Division Chief, Breast Medical Oncology
Professor, Department of Medical Oncology
and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California
Professor Emeritus, UCSF

Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from AstraZeneca Pharmaceuticals LP.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

American Diabetes Association Professional Practice Committee for Diabetes. Pharmacologic approaches to glycemic treatment: Standards of care in diabetes — 2026. Diabetes Care 2026;49(Suppl 1):183-215. Abstract

André F et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: Final overall survival results from SOLAR-1. Ann Oncol 2021;32(2):208-17. Abstract

Cheung Y-MM et al. A targeted approach to phosphoinositide-3-kinase/Akt/mammalian target of rapamycin-induced hyperglycemia. Curr Probl Cancer 2022;46(1):100776. Abstract

Gallagher EJ et al. Managing hyperglycemia and rash associated with alpelisib: Expert consensus recommendations using the Delphi technique. NPJ Breast Cancer 2024;10(1):12. Abstract

Iyengar NM et al. Optimizing clinical monitoring and management guidelines for capivasertib in HR-positive/HER2-negative advanced breast cancer: Expert opinion. NPJ Breast Cancer 2025;12(1):16. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med 2025;392(12):1189-202. Abstract

Kotwal A et al. Patient-centered diabetes care of cancer patients. Curr Diab Rep 2021;21(12):62. Abstract

Llombart-Cussac A et al. Preventing alpelisib-related hyperglycaemia in HR+/HER2-/PIK3CA-mutated advanced breast cancer using metformin (METALLICA): A multicentre, open-label, single-arm, phase 2 trial. EClinicalMedicine 2024:71:102520. Abstract

Rugo H et al. Capivasertib and fulvestrant for patients with hormone receptor-positive advanced breast cancer: Characterization, time course, and management of frequent adverse events from the phase III CAPItello-291 study. ESMO Open 2024;9(9):103697. Abstract

Turner NC et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med 2023;388(22):2058-70. Abstract

  • diabetes
  • diabetology
  • hyperglycemia

Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Antibody-Drug Conjugates for Breast Cancer

Accreditation types: 1.25 ABIM MOC, CME

Expires: March 2027

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Faculty

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

UCSF

Professor Emeritus

Sara M Tolaney

Faculty

Sara M Tolaney

MD, MPH

Dana-Farber Cancer Institute, Boston, Massachusetts

Chief, Division of Breast Oncology

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Assess available Phase III data with HER2-directed antibody-drug conjugate (ADC) therapy as a component of neoadjuvant therapy for patients with high-risk localized breast cancer, and consider the potential clinical role of this novel treatment approach.
  • Evaluate available research findings with HER2-directed ADC therapy for patients with HER2-positive localized breast cancer and residual disease after neoadjuvant treatment.
  • Appraise available research data and clinical and biological factors guiding the selection of first-line therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC).
  • Review published research supporting the use of TROP2-directed ADCs as monotherapy or in combination with anti-PD-1/PD-L1 antibodies for patients with newly diagnosed triple-negative mBC, and use this information to make appropriate treatment recommendations.
  • Evaluate published clinical research findings with TROP2-directed ADCs for relapsed/refractory HR-positive and triple-negative mBC, and optimally incorporate these agents into patient care.
  • Assess the biological rationale for the evaluation of HER2-directed ADCs for HER2-low and HER2-ultralow mBC, and identify patients appropriate for this treatment approach.
  • Discern the side effects and toxicities associated with FDA-approved ADCs in the care of patients with breast cancer, and identify strategies to manage and mitigate those complications.
  • Recall ongoing trials evaluating the potential role of novel ADC-based strategies, and appropriately counsel patients with breast cancer regarding enrollment.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the participant to earn up to 1.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/ADCBreast/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Hope S Rugo, MD
Director, Women’s Cancers Program
Division Chief, Breast Medical Oncology
Professor, Department of Medical Oncology
and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California
Professor Emeritus, UCSF

Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

Sara M Tolaney, MD, MPH
Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aadi Bioscience, Aktis Oncology, Ambrx, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP, Avenzo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Bicycle Therapeutics, BioNTech SE, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Circle Pharma, Cullinan Therapeutics, Daiichi Sankyo Inc, eFFECTOR Therapeutics Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Hengrui Therapeutics Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Launch Therapeutics, Lilly, Menarini Group, Merck, Mersana Therapeutics Inc, Natera Inc, Olema Oncology, Pfizer Inc, Reveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics Inc, Sumitovant Biopharma, Summit Therapeutics, SystImmune Inc, Tango Therapeutics, Tempus, Zuellig Pharma; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Menarini Group, Merck, NanoString Technologies, Novartis, OncoPep, Pfizer Inc, Seagen Inc, Stemline Therapeutics Inc; Travel Support: Arvinas, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Pfizer Inc, Roche Laboratories Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Gilead Sciences Inc.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Cortés J et al. Sacituzumab govitecan in untreated, advanced triple-negative breast cancer. N Engl J Med 2025;393(19):1912-25. Abstract

Dent RA et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial. ESMO 2025;Abstract LBA21.

Fan Y et al. Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multi-center phase III OptiTROP-Breast02 study. ESMO 2025;Abstract LBA23.

Harbeck N et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): A randomised, open-label, multicentre, phase III trial. Ann Oncol 2026;37(2):166-79. Abstract

Hu X et al. Patient-reported outcomes with trastuzumab deruxtecan in hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer: Results from the randomized DESTINY-Breast06 trial. ESMO Open 2025;10(5):105082. Abstract

Hu X et al. Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: Results from a randomized phase III study. ESMO 2025;Abstract LBA24.

Jhaveri KL et al. Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07. San Antonio Breast Cancer Symposium 2025;Abstract GS1-09.

Loibl S et al. Trastuzumab deruxtecan in residual HER2-positive early breast cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Modi S et al. Trastuzumab deruxtecan in HER2-low metastatic breast cancer: Long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial. Nat Med 2025;31(12):4205-13. Abstract

Natsuhara KH et al. Treatment rechallenge after trastuzumab-deruxtecan–related interstitial lung disease: A multi-institution cohort study. ASCO 2025;Abstract 1015.

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Rugo HS et al. Q-TWiST analysis of sacituzumab govitecan vs chemotherapy in previously treated patients with HR+/HER2- metastatic breast cancer. Curr Oncol 2025;32(3):169. Abstract

Sakai H et al. A randomized, double-blind, placebo-controlled phase II study of olanzapine-based prophylactic antiemetic therapy for delayed and persistent nausea and vomiting in patients with HER2-positive or HER2-low breast cancer treated with trastuzumab deruxtecan: ERICA study (WJOG14320B). Ann Oncol 2025;36(1):31-42. Abstract

Song E et al. SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01). ESMO 2025;Abstract LBA19.

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2026;394(6):551-62. Abstract

Tolaney SM et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. ASCO 2025;Abstract LBA109.

Wildiers H et al. Outcomes by hormone receptor (HR) status in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with brain metastases (BM) treated with trastuzumab deruxtecan (T-DXd): A post-hoc subgroup analysis of DESTINY-Breast12. San Antonio Breast Cancer Symposium 2025;Abstract PS5-01-27.

Yin Y et al. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: A randomized phase 3 trial. Nat Med 2025;31(6):1969-75. Abstract

Yin Y et al. Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study. ASCO 2025;Abstract 1019.

  • YIR2025

Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Antibody-Drug Conjugates for Breast Cancer

Accreditation types: 1.5 ABIM MOC, ABS MOC, CME

Expires: March 2027

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Faculty

Hope S Rugo

Faculty

Hope S Rugo

MD

City of Hope Comprehensive Cancer Center, Duarte, California

Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology and Therapeutics Research

UCSF

Professor Emeritus

Sara M Tolaney

Faculty

Sara M Tolaney

MD, MPH

Dana-Farber Cancer Institute, Boston, Massachusetts

Chief, Division of Breast Oncology

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

  • Assess available Phase III data with HER2-directed antibody-drug conjugate (ADC) therapy as a component of neoadjuvant therapy for patients with high-risk localized breast cancer, and consider the potential clinical role of this novel treatment approach.
  • Evaluate available research findings with HER2-directed ADC therapy for patients with HER2-positive localized breast cancer and residual disease after neoadjuvant treatment.
  • Appraise available research data and clinical and biological factors guiding the selection of first-line therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC).
  • Review published research supporting the use of TROP2-directed ADCs as monotherapy or in combination with anti-PD-1/PD-L1 antibodies for patients with newly diagnosed triple-negative mBC, and use this information to make appropriate treatment recommendations.
  • Evaluate published clinical research findings with TROP2-directed ADCs for relapsed/refractory HR-positive and triple-negative mBC, and optimally incorporate these agents into patient care.
  • Assess the biological rationale for the evaluation of HER2-directed ADCs for HER2-low and HER2-ultralow mBC, and identify patients appropriate for this treatment approach.
  • Discern the side effects and toxicities associated with FDA-approved ADCs in the care of patients with breast cancer, and identify strategies to manage and mitigate those complications.
  • Recall ongoing trials evaluating the potential role of novel ADC-based strategies, and appropriately counsel patients with breast cancer regarding enrollment.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/ADCBreast/Presentations/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Hope S Rugo, MD
Director, Women’s Cancers Program
Division Chief, Breast Medical Oncology
Professor, Department of Medical Oncology
and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California
Professor Emeritus, UCSF

Advisory Committees and Consulting Agreements: BioNTech SE, Bristol Myers Squibb, Helsinn Therapeutics (US) Inc, Napo Pharmaceuticals; Contracted Research (Funding to City of Hope): Bicycle Therapeutics, Genentech, a member of the Roche Group, Stemline Therapeutics Inc; Contracted Research (Funding to Prior Institution, UCSF): Ambrx Inc, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc.

Sara M Tolaney, MD, MPH
Chief, Division of Breast Oncology
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aadi Bioscience, Aktis Oncology, Ambrx, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP, Avenzo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Bicycle Therapeutics, BioNTech SE, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Circle Pharma, Cullinan Therapeutics, Daiichi Sankyo Inc, eFFECTOR Therapeutics Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Hengrui Therapeutics Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Launch Therapeutics, Lilly, Menarini Group, Merck, Mersana Therapeutics Inc, Natera Inc, Olema Oncology, Pfizer Inc, Reveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics Inc, Sumitovant Biopharma, Summit Therapeutics, SystImmune Inc, Tango Therapeutics, Tempus, Zuellig Pharma; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Menarini Group, Merck, NanoString Technologies, Novartis, OncoPep, Pfizer Inc, Seagen Inc, Stemline Therapeutics Inc; Travel Support: Arvinas, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Pfizer Inc, Roche Laboratories Inc.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Gilead Sciences Inc.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract

Cortés J et al. Sacituzumab govitecan in untreated, advanced triple-negative breast cancer. N Engl J Med 2025;393(19):1912-25. Abstract

Dent RA et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial. ESMO 2025;Abstract LBA21.

Fan Y et al. Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multi-center phase III OptiTROP-Breast02 study. ESMO 2025;Abstract LBA23.

Harbeck N et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): A randomised, open-label, multicentre, phase III trial. Ann Oncol 2026;37(2):166-79. Abstract

Hu X et al. Patient-reported outcomes with trastuzumab deruxtecan in hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer: Results from the randomized DESTINY-Breast06 trial. ESMO Open 2025;10(5):105082. Abstract

Hu X et al. Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: Results from a randomized phase III study. ESMO 2025;Abstract LBA24.

Jhaveri KL et al. Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07. San Antonio Breast Cancer Symposium 2025;Abstract GS1-09.

Loibl S et al. Trastuzumab deruxtecan in residual HER2-positive early breast cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Modi S et al. Trastuzumab deruxtecan in HER2-low metastatic breast cancer: Long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial. Nat Med 2025;31(12):4205-13. Abstract

Natsuhara KH et al. Treatment rechallenge after trastuzumab-deruxtecan–related interstitial lung disease: A multi-institution cohort study. ASCO 2025;Abstract 1015.

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Rugo HS et al. Q-TWiST analysis of sacituzumab govitecan vs chemotherapy in previously treated patients with HR+/HER2- metastatic breast cancer. Curr Oncol 2025;32(3):169. Abstract

Sakai H et al. A randomized, double-blind, placebo-controlled phase II study of olanzapine-based prophylactic antiemetic therapy for delayed and persistent nausea and vomiting in patients with HER2-positive or HER2-low breast cancer treated with trastuzumab deruxtecan: ERICA study (WJOG14320B). Ann Oncol 2025;36(1):31-42. Abstract

Song E et al. SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): A multicenter, open-label, randomized, phase III study (HORIZON-Breast01). ESMO 2025;Abstract LBA19.

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2026;394(6):551-62. Abstract

Tolaney SM et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. ASCO 2025;Abstract LBA109.

Wildiers H et al. Outcomes by hormone receptor (HR) status in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with brain metastases (BM) treated with trastuzumab deruxtecan (T-DXd): A post-hoc subgroup analysis of DESTINY-Breast12. San Antonio Breast Cancer Symposium 2025;Abstract PS5-01-27.

Yin Y et al. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: A randomized phase 3 trial. Nat Med 2025;31(6):1969-75. Abstract

Yin Y et al. Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study. ASCO 2025;Abstract 1019.

  • YIR2025