Consensus or Controversy? Documenting and Discussing Investigators’ Approaches to the Use of Oral SERDs and Agents Targeting the PI3K/AKT/mTOR Pathway in 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

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

Erica Mayer

Faculty

Erica Mayer

MD, MPH, FASCO

Dana-Farber Cancer Institute, Boston, Massachusetts

Director of Breast Cancer Clinical Research, Breast Oncology Center

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

Joyce O’Shaughnessy

Faculty

Joyce O’Shaughnessy

MD

Baylor University Medical Center Dallas, Texas

Celebrating Women Chair in Breast Cancer Research

Sarah Cannon Research Institute Dallas, Texas

Chair, Breast Disease Committee

Sara M Tolaney

Moderator

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

Nicholas Turner

Faculty

Nicholas Turner

MD, PhD

The Royal Marsden NHS Foundation Trust London, United Kingdom

Head, Ralph Lauren Centre for Breast Cancer Research Breast Unit Director, Clinical Research Director, The Royal Marsden and Institute of Cancer Research NIHR Biomedical Research Centre

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Celcuity, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics 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: Current and Future Roles of Agents Targeting the PI3K/AKT/mTOR Pathway and Oral Selective Estrogen Receptor Degraders (SERDs) in First-Line Therapy for Hormone Receptor (HR)-Positive, HER2-Negative Metastatic Breast Cancer (mBC)

  • Optimal approach to and timing of biomarker assessment for patients with HR-positive mBC; increasing relevance of biomarker evaluation in the up-front setting
  • Key findings, including overall survival data, from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib and fulvestrant as first-line therapy for patients with HR-positive, HER2-negative mBC with a PIK3CA mutation whose disease progressed during or within 12 months of adjuvant endocrine therapy
  • FDA approval of inavolisib/palbociclib/fulvestrant and clinical role in the treatment of newly diagnosed HR-positive, HER2-negative mBC with a PIK3CA mutation
  • Design, eligibility criteria and key endpoints of the Phase III SERENA-6 study evaluating a switch from an aromatase inhibitor (AI) to camizestrant after detection of an emergent ESR1 mutation during first-line therapy for HR-positive, HER2-negative mBC
  • Published findings from the SERENA-6 trial; potential role of serial ESR1 testing using circulating tumor DNA (ctDNA) and early therapeutic switching in the care of patients found to harbor mutations
  • Ongoing Phase III trials evaluating PI3K/AKT/mTOR pathway inhibitors (eg, the INAVO123, CAPItello-292 and VIKTORIA-2 studies) and oral SERDs (eg, the SERENA-4 and persevERA studies) as a component of first-line therapy for patients with HR-positive, HER2-negative mBC; estimated completion dates

MODULE 2: Role of Oral SERD Monotherapy in the Treatment of Progressive HR-Positive, HER2-Negative mBC

  • Structural and mechanistic similarities and differences between fulvestrant and approved and investigational oral SERDs; implications for antitumor activity, tolerability and ease of use
  • Published efficacy and safety results from the Phase III EMERALD trial and real-world datasets evaluating elacestrant for pretreated HR-positive, HER2-negative mBC
  • Updated efficacy results documented with imlunestrant monotherapy in the Phase III EMBER-3 study evaluating that agent alone or in combination with abemaciclib for patients with HR-positive, HER2-negative mBC pretreated with endocrine therapy with or without a CDK4/6 inhibitor
  • FDA approvals of elacestrant and imlunestrant for previously treated HR-positive, HER2-negative, ESR1-mutated mBC; optimal incorporation into management algorithms
  • Available findings with other oral SERDs, such as camizestrant and giredestrant, administered as monotherapy for advanced HR-positive, HER2-negative breast cancer

MODULE 3: Potential Use of Oral SERD-Containing Combination Regimens in Managing Progressive HR-Positive, HER2-Negative mBC

  • Biological rationale for combining oral SERDs with other systemic therapies for HR-positive mBC
  • Updated efficacy and safety outcomes documented in the imlunestrant/abemaciclib arm of the EMBER-3 trial among patients with and without ESR1 mutations
  • Indications, if any, for the nonresearch use of imlunestrant in combination with abemaciclib for endocrine therapy-pretreated, HR-positive, HER2-positive mBC
  • Presented data from the Phase III evERA study of giredestrant in combination with everolimus versus standard endocrine therapy in combination with everolimus for pretreated HR-positive, HER2-negative mBC
  • Potential clinical role of giredestrant/everolimus for previously treated HR-positive, HER2-positive mBC
  • Early-phase data with and ongoing evaluation of other oral SERD-containing combination strategies for progressive HR-positive, HER2-negative mBC

MODULE 4: Clinical Utility of Agents Targeting the PI3K/AKT/mTOR Pathway for Patients with Progressive HR-Positive, HER2-Negative mBC

  • Key efficacy and safety data from the Phase III CAPItello-291 study evaluating capivasertib/fulvestrant for HR-positive, HER2-negative mBC progressing on endocrine therapy with or without a CDK4/6 inhibitor
  • FDA approval of capivasertib for patients with PIK3CA/AKT1/PTEN alterations and current therapeutic role with regard to other evidence-based options
  • Mechanistic similarities and differences between gedatolisib and currently approved therapies targeting the PI3K/AKT/mTOR pathway in HR-positive mBC; implications for antitumor activity
  • 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 AI
  • Recently published efficacy and safety findings from the PIK3CA wild-type cohort of VIKTORIA-1; anticipated readout of the PIK3CA-mutated cohort
  • Potential role of gedatolisib-containing combination therapy for pretreated HR-positive, HER2-negative mBC that is PIK3CA wild type and PIK3CA mutated

MODULE 5: Potential Use of Oral SERDs for HR-Positive, HER2-Negative Localized BCr

  • Rationale for the investigation of oral SERDs as adjuvant therapy for patients with HR-positive, HER2-negative localized breast cancer
  • Design, eligibility criteria and primary and second endpoints of the Phase III lidERA Breast Cancer study evaluating adjuvant giredestrant versus physician’s choice of adjuvant endocrine monotherapy for patients with HR-positive, HER2-negative localized breast cancer
  • Improvement in invasive disease-free survival and other key efficacy outcomes documented with adjuvant giredestrant in the lidERA Breast Cancer trial
  • Tolerability profile of giredestrant versus standard adjuvant endocrine therapy in the lidERA Breast Cancertrial
  • Potential clinical role of adjuvant giredestrant for patients with HR-positive, HER2-negative localized breast cancer
  • Early data with and ongoing Phase III trials (eg, the ELEGANT, TREAT ctDNA, EMBER-4, CAMBRIA-1 and CAMBRIA-2 studies) of other oral SERDs in the adjuvant setting

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
Upon completion of this activity, participants should be able to

  • Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
  • Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences among available and investigational oral selective estrogen receptor degraders (SERDs).
  • Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor in order to optimally integrate these agents into the care of appropriately selected patients.
  • Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA in informing early therapeutic switching for patients with ER-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy.
  • Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens.
  • Recognize the frequency of PIK3CA/AKT/PTEN alterations in patients with hormone receptor (HR)-positive mBC, and employ evidence-based approaches to target these aberrations for appropriate candidates 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 employing this strategy for patients with HR-positive, PIK3CA wild-type and PIK3CA-mutant mBC.
  • Appreciate side effects associated with available and investigational oral SERDs and other agents targeting the PI3K/AKT/mTOR pathway, and use this information to develop supportive care plans for patients receiving these treatments.
  • Assess ongoing clinical research studies evaluating novel applications of oral SERDs and PI3K/AKT/mTOR inhibitor-based approaches, and counsel patients regarding the potential benefits of trial participation.

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. 

Dr HurvitzAdvisory 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 MayerConsulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis. Dr O’ShaughnessyAdvisory Committees and Consulting Agreements: Aadi Bioscience, Agendia Inc, Amgen Inc, Aptitude Health, AstraZeneca Pharmaceuticals LP, BioNTech SE, Bristol Myers Squibb, Daiichi Sankyo Inc, Duality Biologics, Eisai Inc, Ellipses Pharma, Exact Sciences Corporation, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Guardant Health, HiberCell, Jazz Pharmaceuticals Inc, Johnson & Johnson, Lilly, Menarini Group, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Pfizer Inc, Pierre Fabre, Puma Biotechnology Inc, RayzeBio, Roche Laboratories Inc, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Summit Therapeutics, Tempus, TerSera Therapeutics LLC. Dr TolaneyConsulting Agreements: Aadi Bioscience, Ambrx, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LPAktis OncologyAvenzo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Bicycle Therapeutics, BioNTech SE, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals IncBoundless Bio, Bristol Myers Squibb, CelcuityCircle PharmaCullinan Therapeutics, Daiichi Sankyo IncDenali Therapeutics, eFFECTOR Therapeutics Inc, Eisai Inc, Genentech, a member of the Roche Group, Gilead Sciences IncHengrui Therapeutics Inc, Jazz Pharmaceuticals Inc, Johnson & JohnsonLaunch TherapeuticsLilly, Menarini GroupMerck, Mersana Therapeutics Inc, Natera IncNovartis, Olema Oncology, Pfizer IncReveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics IncSumitovant Biopharma, Summit Therapeutics, SystImmune Inc, Tango Therapeutics, TempusZuellig 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: Arvinas, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Pfizer Inc, Roche Laboratories Inc.

MODERATOR
To be announced.

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, Celcuity, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics 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.

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See you on Sunday, May 31


Format:

Chicago, IL

Date & Time:

Sunday, May 31 7:00 PM — 9:00 PM CT

The Implications of Recent Datasets for the Current and Future Management of Breast Cancer — An ASCO 2025 Review

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: September 2026

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Faculty

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

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

  • Evaluate recently presented clinical research findings to determine their effect on the management of localized and metastatic breast cancer (mBC).
  • Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for patients with hormone receptor (HR)-positive localized or metastatic breast cancer, and provide appropriate counsel regarding the optimal use of these agents.
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations and ESR1 mutations in patients with HR-positive, HER2-negative mBC, and employ evidence-based approaches designed to target these aberrations.
  • Evaluate published and emerging research to effectively inform the selection and sequencing of available therapeutic agents and regimens for patients with HER2-positive localized and metastatic breast cancer.
  • Discuss available research establishing the efficacy of PARP inhibitors for localized or metastatic breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify patients for whom treatment with these agents would be appropriate.
  • Appreciate the incidence, characteristics and clinical relevance of HER2-low or HER2-ultralow mBC, and understand available research findings with HER2-directed antibody-drug conjugates (ADCs) for these patients.
  • Interrogate published and emerging Phase III research documenting the efficacy of TROP2-directed ADCs for patients with mBC to determine the current and potential clinical applicability of these approaches.
  • Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for localized and metastatic breast cancer.

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 1.25 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 components 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 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 components 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 Program: 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/PostASCO2025/Breast/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:

Sara A Hurvitz, MD, FACP
Professor of Medicine
Smith Family Endowed Chair in Women’s Health
Senior Vice President, Clinical Research Division
Fred Hutchinson Cancer Center
Head, Division of Hematology/Oncology
Department of Medicine
UW Medicine
Seattle, Washington

Advisory Committees: BeOne, BriaCell, BridgeBio Oncology Therapeutics, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Luminate, Mersana Therapeutics Inc, Novartis, Prelude Therapeutics; Consulting Agreements: ALX Oncology, Bayer HealthCare Pharmaceuticals, BeOne, Blueprint Medicines, EMBioSys, Jazz Pharmaceuticals Inc, Genentech, a member of the Roche Group; Contracted Research: Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Celcuity, Daiichi Sankyo Inc, Dantari, F Hoffmann-La Roche Ltd, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Greenwich LifeSciences Inc, Jazz Pharmaceuticals Inc, Lilly, MacroGenics Inc, Menarini Group, Novartis, Orum Therapeutics, Pfizer Inc, Radius Health Inc, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Zymeworks Inc; Data and Safety Monitoring Boards/Committees: Atossa Therapeutics, Nonrelevant Financial Relationships: InClin, Quantum Leap Healthcare Collaborative.

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, Novartis, Pfizer Inc, Reveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics Inc, Sumitovant Biopharma, Summit Therapeutics, SystImmune Inc, Tango Therapeutics, 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, 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals 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, Gilead Sciences Inc, Lilly, and Novartis.

Release date: September 2025
Expiration date: September 2026

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

Curigliano G et al. Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator’s choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial. ASCO 2025;Abstract 1001.

Dent RA et al. Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/ultralow, hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ASCO 2025;Abstract 1013.

El Saghir NS et al. First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive hormone receptor (HR)+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without liver metastases (mets) from RIGHT Choice. ASCO 2025;Abstract 1069.

Gao H-F et al. De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): A multicentre, open-label, randomised, phase 3 trial. ASCO 2025;Abstract LBA500.

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and/or BRCA2 pathogenic variants and high-risk HER2-negative primary breast cancer: Longer term follow-up. SABCS 2024;Abstract GS1-09.

Hamilton EP et al. Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study. ASCO 2025;Abstract LBA1000.

Kalinsky K et al. Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age. ASCO 2025;Abstract 516.

Lin N et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results. ESMO 2024;Abstract LBA18.

Lin NU et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). ASCO 2020;Abstract 1005.

Mayer EL et al. The TRADE study: A phase 2 trial to assess the tolerability of abemaciclib dose escalation in early-stage HR+/HER2- breast cancer. ASCO 2025;Abstract 517.

Metzger O et al. AFT-38 PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer. SABCS 2024;Abstract GS2-12.

Mulder D et al. Use of artificial intelligence–assistance software for HER2-low and HER2-ultralow IHC interpretation training to improve diagnostic accuracy of pathologists and expand patients’ eligibility for HER2-targeted treatment. ASCO 2025;Abstract 1014.

O’Shaughnessy J et al. HERTHENA-Breast03: A phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer. ASCO 2025;Abstract TPS629.

O’Shaughnessy J et al. Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. ASCO 2025;Abstract 1060.

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

Sammons S et al. Brain metastases in metastatic breast cancer: Prevalence per line of treatment and cumulative incidence in a cohort of 18075 real-world patients. SABCS 2023;Abstract PS11-01.

Singer CF et al. Prospective randomized phase II trial to assess the efficacy and safety of neo-adjuvant olaparib/carboplatin (OC) in comparison to docetaxel/epirubicin/cyclophosphamide (TAC) in patients with early triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD): Primary results from the ABCSG 45 trial. ASCO 2025;Abstract 510.

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.

Tolaney SM et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Turner NC et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025;Abstract LBA4.

Turner NC et al. INAVO120: Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). ASCO 2025;Abstract 1003.

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

The Implications of Recent Datasets for the Current and Future Management of Breast Cancer — An ASCO 2025 Review

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: September 2026

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Faculty

Sara A Hurvitz

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

Sara M Tolaney

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

  • Evaluate recently presented clinical research findings to determine their effect on the management of localized and metastatic breast cancer (mBC).
  • Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for patients with hormone receptor (HR)-positive localized or metastatic breast cancer, and provide appropriate counsel regarding the optimal use of these agents.
  • Recognize the frequency of PIK3CA/AKT1/PTEN alterations and ESR1 mutations in patients with HR-positive, HER2-negative mBC, and employ evidence-based approaches designed to target these aberrations.
  • Evaluate published and emerging research to effectively inform the selection and sequencing of available therapeutic agents and regimens for patients with HER2-positive localized and metastatic breast cancer.
  • Discuss available research establishing the efficacy of PARP inhibitors for localized or metastatic breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify patients for whom treatment with these agents would be appropriate.
  • Appreciate the incidence, characteristics and clinical relevance of HER2-low or HER2-ultralow mBC, and understand available research findings with HER2-directed antibody-drug conjugates (ADCs) for these patients.
  • Interrogate published and emerging Phase III research documenting the efficacy of TROP2-directed ADCs for patients with mBC to determine the current and potential clinical applicability of these approaches.

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, these programs have 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, 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/PostASCO2025/Breast/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:

Sara A Hurvitz, MD, FACP
Professor of Medicine
Smith Family Endowed Chair in Women’s Health
Senior Vice President, Clinical Research Division
Fred Hutchinson Cancer Center
Head, Division of Hematology/Oncology
Department of Medicine
UW Medicine
Seattle, Washington

Advisory Committees: BeOne, BriaCell, BridgeBio Oncology Therapeutics, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Luminate, Mersana Therapeutics Inc, Novartis, Prelude Therapeutics; Consulting Agreements: ALX Oncology, Bayer HealthCare Pharmaceuticals, BeOne, Blueprint Medicines, EMBioSys, Jazz Pharmaceuticals Inc, Genentech, a member of the Roche Group; Contracted Research: Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Celcuity, Daiichi Sankyo Inc, Dantari, F Hoffmann-La Roche Ltd, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, GSK, Greenwich LifeSciences Inc, Jazz Pharmaceuticals Inc, Lilly, MacroGenics Inc, Menarini Group, Novartis, Orum Therapeutics, Pfizer Inc, Radius Health Inc, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Zymeworks Inc; Data and Safety Monitoring Boards/Committees: Atossa Therapeutics, Nonrelevant Financial Relationships: InClin, Quantum Leap Healthcare Collaborative.

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, Novartis, Pfizer Inc, Reveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics Inc, Sumitovant Biopharma, Summit Therapeutics, SystImmune Inc, Tango Therapeutics, 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, 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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals 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, Gilead Sciences Inc, Lilly, and Novartis.

Release date: September 2025
Expiration date: September 2026

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

Curigliano G et al. Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator’s choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial. ASCO 2025;Abstract 1001.

Dent RA et al. Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/ultralow, hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ASCO 2025;Abstract 1013.

El Saghir NS et al. First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive hormone receptor (HR)+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without liver metastases (mets) from RIGHT Choice. ASCO 2025;Abstract 1069.

Gao H-F et al. De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): A multicentre, open-label, randomised, phase 3 trial. ASCO 2025;Abstract LBA500.

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and/or BRCA2 pathogenic variants and high-risk HER2-negative primary breast cancer: Longer term follow-up. SABCS 2024;Abstract GS1-09.

Hamilton EP et al. Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study. ASCO 2025;Abstract LBA1000.

Kalinsky K et al. Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age. ASCO 2025;Abstract 516.

Lin N et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results. ESMO 2024;Abstract LBA18.

Lin NU et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). ASCO 2020;Abstract 1005.

Mayer EL et al. The TRADE study: A phase 2 trial to assess the tolerability of abemaciclib dose escalation in early-stage HR+/HER2- breast cancer. ASCO 2025;Abstract 517.

Metzger O et al. AFT-38 PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer. SABCS 2024;Abstract GS2-12.

Mulder D et al. Use of artificial intelligence–assistance software for HER2-low and HER2-ultralow IHC interpretation training to improve diagnostic accuracy of pathologists and expand patients’ eligibility for HER2-targeted treatment. ASCO 2025;Abstract 1014.

O’Shaughnessy J et al. HERTHENA-Breast03: A phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer. ASCO 2025;Abstract TPS629.

O’Shaughnessy J et al. Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. ASCO 2025;Abstract 1060.

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

Sammons S et al. Brain metastases in metastatic breast cancer: Prevalence per line of treatment and cumulative incidence in a cohort of 18075 real-world patients. SABCS 2023;Abstract PS11-01.

Singer CF et al. Prospective randomized phase II trial to assess the efficacy and safety of neo-adjuvant olaparib/carboplatin (OC) in comparison to docetaxel/epirubicin/cyclophosphamide (TAC) in patients with early triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD): Primary results from the ABCSG 45 trial. ASCO 2025;Abstract 510.

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.

Tolaney SM et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Turner NC et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. ASCO 2025;Abstract LBA4.

Turner NC et al. INAVO120: Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). ASCO 2025;Abstract 1003.

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

Rounds with the Investigator — A Discussion on the Role of Endocrine-Based Therapy for HR-Positive Breast Cancer

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Faculty

Sara A Hurvitz

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

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

LEARNING OBJECTIVES

  • Consider available clinical trial findings with CDK4/6 inhibitors for localized hormone receptor (HR)-positive, HER2-negative breast cancer, and identify patients for whom adjuvant treatment with one of these agents may be appropriate.
  • Evaluate biological and patient- and treatment-related factors to personalize the selection and sequencing of therapy for HR-positive, HER2-negative metastatic breast cancer (mBC).
  • Review available research documenting the correlation between the presence of various biomarkers, such as PIK3CA/AKT1/PTEN alterations and ESR1 mutations, and response to specific therapies, and develop optimal molecular testing algorithms for patients with HR-positive mBC.
  • Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive mBC, and use this information to appropriately counsel patients about the optimal clinical use of these agents.
  • Employ evidence-based approaches to targeting PI3K pathway mutations in patients with HR-positive mBC.
  • Understand the mechanism of action of, published research findings with and current and future clinical roles for oral selective estrogen receptor degraders for patients with HR-positive mBC.
  • Interrogate published Phase III research documenting the efficacy of AKT inhibitors for patients with progressive HR-positive mBC to determine the current clinical applicability of this approach.
  • Recognize the side effects and toxicities associated with available and investigational endocrine-based therapies used in the care of patients with breast cancer, and identify management and mitigation strategies.

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

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 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 these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to and 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 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 components 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 Program: 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/SABCS2024/Review/HRPosEndocrine/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 conflicts of interest 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:

Sara A Hurvitz, MD, FACP
Professor
Senior Vice President
Clinical Research Division
Fred Hutchinson Cancer Center
Head, Division of Hematology/Oncology
UW Medicine
Seattle, Washington

Contracted Research: Ambrx, Amgen Inc, Arvinas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Celcuity, CytomX Therapeutics, Daiichi Sankyo Inc, Dantari, Dignitana AB, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Greenwich LifeSciences Inc, GSK, Lilly, MacroGenics Inc, Novartis, OBI Pharma Inc, Orinove Inc, Orum Therapeutics, Pfizer Inc, Phoenix Molecular Designs, Pieris Pharmaceuticals Inc, Puma Biotechnology Inc, Radius Health Inc, Samumed, Sanofi, Seagen Inc, Stemline Therapeutics Inc, Zymeworks 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 conflicts of interest 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, Lilly, Novartis, and Stemline Therapeutics Inc.

Release date: March 2025
Expiration date: March 2026

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

Dr Hurvitz

Fasching PA et al. Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): 4-year outcomes from the NATALEE trial. ESMO 2024;Abstract LBA13.

Goetz MP et al. Impact of dose reductions on adjuvant abemaciclib efficacy for patients with high-risk early breast cancer: Analyses from the monarchE study. NPJ Breast Cancer 2024;10(1):34. Abstract

Hamilton E et al. Impact of ribociclib dose reduction on efficacy in patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) early breast cancer (EBC) in NATALEE. San Antonio Breast Cancer Symposium 2024;Abstract P1-11-16.

Harbeck N et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol 2021;32(12):1571-81. Abstract

Johnston SRD et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol 2023;24(1):77-90. Abstract

Rastogi P et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987-93. Abstract

Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol 2022;33(6):616-27. Abstract

Slamon DJ et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer: Primary results from the phase III NATALEE trial. ASCO 2023;Abstract LBA500.

 

Dr Wander

Finn RS et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. ASCO 2022;Abstract LBA1003.

Goetz M et al. MONARCH 3: Final overall survival results of abemaciclib plus a nonsteroidal aromatase inhibitor as first-line therapy for HR+, HER2- advanced breast cancer. San Antonio Breast Cancer Symposium 2023;Abstract GS01-12.

Hortobagyi GN et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med 2022;386(10):942-50. Abstract

Hortobagyi GN et al. Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (RIB). ESMO 2021;Abstract LBA17_PR.

Kalinsky K et al. Abemaciclib plus fulvestrant vs fulvestrant alone for HR+, HER2- advanced breast cancer following progression on a prior CDK4/6 inhibitor plus endocrine therapy: Primary outcome of the phase 3 postMONARCH trial. ASCO 2024;Abstract LBA1001.

Lu Y-S et al. Final results of RIGHT choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract

Slamon DJ et al. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol 2024;42(9):994-1000. Abstract

Sonke GS et al. Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer. Nature 2024;636(8042):474-80. Abstract

 

Dr Goetz

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

André F et al. Alpelisib for PIK3CA-nutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract

Baselga J et al. Everolimus in postmenopausal hormone-receptor–positive advanced breast cancer. N Engl J Med 2012;366(6):520-9. Abstract

Chavez-MacGregor M et al. Phase III randomized, placebo-controlled trial of endocrine therapy ± 1 year of everolimus in patients with high-risk, hormone receptor-positive, early-stage breast cancer. J Clin Oncol 2024;42(25):3012-21. Abstract

Goetz MP et al. Landscape of baseline and acquired genomic alterations in circulating tumor DNA with abemaciclib alone or with endocrine therapy in advanced breast cancer. Clin Cancer Res 2024;30(10):2233-44. Abstract

Jhaveri KL et al. Inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: Phase III INAVO120 primary analysis. San Antonio Breast Cancer Symposium 2023;Abstract GS03-13.

Juric D et al. First-line inavolisib/placebo + palbociclib + fulvestrant (inavo/pbo+palbo+fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 phase III randomized trial additional analyses. ASCO 2024;Abstract 1003.

Tolaney SM et al. Overall survival and exploratory biomarker analyses of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus chemotherapy in HR+, HER2+ metastatic breast cancer patients. Clin Cancer Res 2024;30(1):39-49. Abstract

 

Dr Jhaveri

Howell S et al. Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant HR positive/HER2-negative advanced breast cancer: Exploratory analysis of PFS by AKT pathway gene from the phase 3 CAPItello-291 trial. San Antonio Breast Cancer Symposium 2023;Abstract PS17-03.

Howell SJ et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION): Overall survival, updated progression-free survival, and expanded biomarker analysis from a randomised, phase 2 trial. Lancet Oncol 2022;23(7):851-64​. Abstract

Jones RH et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): A multicentre, randomised, controlled, phase 2 trial. Lancet Oncol 2020;21(3):345-57.​ Abstract

Oliveira M et al. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): Patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol 2024;25(9):1231-44. Abstract

Oliveira M et al. Capivasertib and fulvestrant for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Subgroup analyses from the Phase 3 CAPItello-291 trial. ESMO Breast 2023;Abstract 187O.

Rugo HS et al. Capivasertib and fulvestrant (F) for patients (pts) with aromatase inhibitor (AI)-resistant HR+/HER2- advanced breast cancer (ABC): Second progression-free survival (PFS2) and time to first subsequent chemotherapy (TFSC) in the CAPItello-291 trial. ESMO Breast 2024;Abstract 183MO.

Rugo HS 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). Abstract

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

Turner NC et al. Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the phase III CAPItello-291 trial. San Antonio Breast Cancer Symposium 2022;Abstract GS3-04.

 

Dr Kaklamani

Bardia A et al. Elacestrant in ER+, HER2- metastatic breast cancer with ESR1-mutated tumors: Subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res 2024;30(19):4299-309. Abstract

Bardia A et al. ELEGANT: Elacestrant versus standard endocrine therapy in women & men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. San Antonio Breast Cancer Symposium 2024;Abstract P2-08-21.

Bidard F-C et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol 2022;40(28):3246-56. Abstract

Chaudhary N et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. NPJ Breast Cancer 2024;10(1):15. Abstract

Jhaveri KL et al. Imlunestrant, an oral selective estrogen receptor degrader, as monotherapy and in combination with targeted therapy in estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Phase Ia/Ib EMBER study. J Clin Oncol 2024;42(35):4173-86. Abstract

Jhaveri KL et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy and combined with abemaciclib, for patients w/ ER+, HER2- advanced breast cancer (ABC), pretreated w/ endocrine therapy (ET): Results of the phase 3 EMBER-3 trial. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01.

Martin Jimenez M et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase II, randomised, open-label acelERA BC study. ESMO 2022;Abstract 211MO.

Martín M et al. Giredestrant for estrogen receptor-positive, HER2-negative, previously treated advanced breast cancer: Results from the randomized, phase II acelERA breast cancer study. J Clin Oncol 2024;42(18):2149-60. Abstract

Oliveira M et al. Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose phase 2 SERENA-2 trial. San Antonio Breast Cancer Symposium 2022;Abstract GS3-02.

Rugo H et al. Elacestrant combinations in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase 1b/2, open-label, umbrella study. San Antonio Breast Cancer Symposium 2024;Abstract PS7-06.

Ruiz-Borrego M et al. Results from SERENA-1 parts K/L: A phase 1 study of the next-generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with ribociclib in women with ER-positive, HER2 negative advanced breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract PS7-08.

Sivakumar S et al. Tissue and liquid biopsy profiling reveal convergent tumor evolution and therapy evasion in breast cancer. Nat Commun 2022;13(1):7495. Abstract

Tolaney SM et al. AMEERA-3: Randomized phase II study of amcenestrant (oral selective estrogen receptor degrader) versus standard endocrine monotherapy in estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2023;41(24):4014-24. Abstract

Tolaney SM et al. AMEERA-3, a phase II study of amcenestrant (AMC) versus endocrine treatment of physician’s choice (TPC) in patients (pts) with endocrine-resistant ER+/HER2− advanced breast cancer (aBC). ESMO 2022;Abstract 212MO.

Turner NC et al. ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor–positive breast cancer: A combined analysis of the phase III SoFEA and EFECT Ttials. Clin Cancer Res 2020;26(19):5172-7. Abstract