Optimizing Biomarker Assessment and Related Treatment Decision-Making for Patients with HR-Positive Metastatic Breast Cancer

Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: April 2027

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Faculty

Seth Wander

Seth Wander

MD, PhD

Massachusetts General Hospital, Boston, Massachusetts

Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

Harvard Medical School, Boston, Massachusetts

Assistant Professor 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

  • 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 HR-positive, HER2-negative metastatic breast cancer (mBC).
  • Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant mBC and determine the appropriate timing of and platforms to test for these abnormalities.
  • Recognize the frequency of PIK3CA/AKT/PTEN pathway abnormalities in patients with HR-positive mBC, and employ evidence-based approaches designed to document and subsequently target these aberrations in individuals with newly diagnosed and relapsed/refractory disease.
  • Interrogate published research findings documenting the efficacy of oral selective estrogen receptor degraders for patients with ER-positive, HER2-negative, ESR1 mutation-positive mBC experiencing disease progression on standard endocrine therapy in combination with a CDK4/6 inhibitor in order to optimally integrate these agents into the care of appropriately selected individuals.
  • Review available and emerging research data evaluating the role of serial ESR1 testing using circulating tumor DNA to inform early therapeutic switching in patients with HR-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy.

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 components and post-tests, 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 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 Interview: ResearchToPractice.com/OncologyTodayBiomarkersHRPosmBC25/Video and evaluation ResearchToPractice.com/OncologyTodayBiomarkersHRPosmBC25/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 these activities. 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:

Seth Wander, MD, PhD
Director of Precision Medicine
Termeer Center for Targeted Therapies
Director of Translational Research
Breast Oncology Program
Massachusetts General Hospital
Assistant Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio Inc, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, 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.

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, and Stemline Therapeutics Inc. 

Release date: April 2026
Expiration date: April 2027

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

Bidard FC et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

Bidard F et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025;Abstract RF7-03.

Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

Burstein HJ et al. Testing for ESR1 mutations to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline rapid recommendation update. J Clin Oncol 2023;41(18):3423-5. Abstract

Cortes J et al. Phase III study of first-line (1L) inavolisib/placebo + a CDK4/6 inhibitor + letrozole (INAVO/PBO + CDK4/6i + LET) in participants (pts) with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-sensitive advanced breast cancer (aBC). ESMO 2025;Abstract 408TiP.

Iams WT et al. Concurrent tissue and circulating tumor DNA molecular profiling to detect guideline-based targeted mutations in a multicancer cohort. JAMA Netw Open 2024;7(1):e2351700. Abstract

Jeselsohn R et al. ESR1 mutations — A mechanism for acquired endocrine resistance in breast cancer.Nat Rev Clin Oncol 2015;12(10):573-83. Abstract

Malorni L et al. Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer 2023;186:1-11. Abstract

Malorni L et al. Serum thymidine kinase 1 activity in patients with hormone receptor positive (HR+)/HER2 negative (HER2-) advanced breast cancer (aBC) treated in first-line with ribociclib (R) and letrozole (L) in the BioItaLEE trial. ESMO 2021;Abstract 292P.

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Michaels EM et al. Associations between circulating tumor DNA genomic profiles and serum thymidine kinase patterns in patients with advanced, hormone receptor-positive, HER2-negative (HR+/HER-) breast cancer initiating treatment with a CDK4/6 inhibitor (CDK4/6i). San Antonio Breast Cancer Symposium 2025;Abstract PS2-10-21.

Saura C et al. Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial. San Antonio Breast Cancer Symposium 2024;Abstract PS7-01.

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.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med2024;391(17):1584-96. Abstract

Turner NC et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol 2023;19(8):559-73. Abstract

Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

Vasan N, Cantley LC. At a crossroads: How to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy. Nat Rev Clin Oncol 2022;19(7):471-85. Abstract

  • Oncology Today

Optimizing Biomarker Assessment and Related Treatment Decision-Making for Patients with HR-Positive Metastatic Breast Cancer

Accreditation types: 1 ABIM MOC, ABS MOC, CME

Expires: April 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

Seth Wander

Seth Wander

MD, PhD

Massachusetts General Hospital, Boston, Massachusetts

Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

Harvard Medical School, Boston, Massachusetts

Assistant Professor 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

  • 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 HR-positive, HER2-negative metastatic breast cancer (mBC).
  • Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant mBC and determine the appropriate timing of and platforms to test for these abnormalities.
  • Recognize the frequency of PIK3CA/AKT/PTEN pathway abnormalities in patients with HR-positive mBC, and employ evidence-based approaches designed to document and subsequently target these aberrations in individuals with newly diagnosed and relapsed/refractory disease.
  • Interrogate published research findings documenting the efficacy of oral selective estrogen receptor degraders for patients with ER-positive, HER2-negative, ESR1 mutation-positive mBC experiencing disease progression on standard endocrine therapy in combination with a CDK4/6 inhibitor in order to optimally integrate these agents into the care of appropriately selected individuals.
  • Review available and emerging research data evaluating the role of serial ESR1 testing using circulating tumor DNA to inform early therapeutic switching in patients with HR-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy.

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 Lecture: Research To Practice designates this enduring material 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 these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1 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 Lecture: ResearchToPractice.com/OncologyTodayBiomarkersHRPosmBC25/Presentation and evaluation ResearchToPractice.com/OncologyTodayBiomarkersHRPosmBC25/Presentation/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 these activities. 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:

Seth Wander, MD, PhD
Director of Precision Medicine
Termeer Center for Targeted Therapies
Director of Translational Research
Breast Oncology Program
Massachusetts General Hospital
Assistant Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio Inc, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, 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.

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, and Stemline Therapeutics Inc. 

Release date: April 2026
Expiration date: April 2027

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

Bidard FC et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

Bidard F et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025;Abstract RF7-03.

Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

Burstein HJ et al. Testing for ESR1 mutations to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline rapid recommendation update. J Clin Oncol 2023;41(18):3423-5. Abstract

Cortes J et al. Phase III study of first-line (1L) inavolisib/placebo + a CDK4/6 inhibitor + letrozole (INAVO/PBO + CDK4/6i + LET) in participants (pts) with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-sensitive advanced breast cancer (aBC). ESMO 2025;Abstract 408TiP.

Iams WT et al. Concurrent tissue and circulating tumor DNA molecular profiling to detect guideline-based targeted mutations in a multicancer cohort. JAMA Netw Open 2024;7(1):e2351700. Abstract

Jeselsohn R et al. ESR1 mutations — A mechanism for acquired endocrine resistance in breast cancer.Nat Rev Clin Oncol 2015;12(10):573-83. Abstract

Malorni L et al. Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer 2023;186:1-11. Abstract

Malorni L et al. Serum thymidine kinase 1 activity in patients with hormone receptor positive (HR+)/HER2 negative (HER2-) advanced breast cancer (aBC) treated in first-line with ribociclib (R) and letrozole (L) in the BioItaLEE trial. ESMO 2021;Abstract 292P.

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Michaels EM et al. Associations between circulating tumor DNA genomic profiles and serum thymidine kinase patterns in patients with advanced, hormone receptor-positive, HER2-negative (HR+/HER-) breast cancer initiating treatment with a CDK4/6 inhibitor (CDK4/6i). San Antonio Breast Cancer Symposium 2025;Abstract PS2-10-21.

Saura C et al. Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial. San Antonio Breast Cancer Symposium 2024;Abstract PS7-01.

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.

Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med2024;391(17):1584-96. Abstract

Turner NC et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol 2023;19(8):559-73. Abstract

Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

Vasan N, Cantley LC. At a crossroads: How to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy. Nat Rev Clin Oncol 2022;19(7):471-85. Abstract

  • Oncology Today

Recent Advances in Cancer Care — New Paradigms, Novel Agents and What It Means for the Oncology Nurse: Targeting the PI3K/AKT/mTOR Pathway in HR-Positive Metastatic Breast Cancer

A Complimentary NCPD Symposium Held During the 51st Annual ONS Congress

Program Schedule — Central Time

11:45 AM – 12:15 PM — Registration and Lunch
12:15 PM – 1:45 PM — Educational Meeting

Location

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

Meeting Room

Grand Ballroom A-F (Third Floor)

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

Faculty

Reva Basho

Faculty

Reva Basho

MD

Ellison Medical Institute, Los Angeles, California

Breast Medical Oncology, Chief Medical Officer

Kelly Fischer

Faculty

Kelly Fischer

MSN, FNP-BC

Dana-Farber Cancer Institute, Boston, Massachusetts

Family Nurse Practitioner

Melissa Rikal

Faculty

Melissa Rikal

FNP-BC, AOCNP

Sarah Cannon Research Institute, Nashville, Tennessee

Nurse Practitioner

Seth Wander

Moderator

Seth Wander

MD, PhD

Massachusetts General Hospital, Boston, Massachusetts

Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

Harvard Medical School, Boston, Massachusetts

Assistant Professor of Medicine

Meeting space has been assigned to provide a symposium supported by AstraZeneca Pharmaceuticals LP, Celcuity, and Genentech, a member of the Roche Group, during the Oncology Nursing Society’s (ONS) 51st Annual Congress, May 13-17, 2026 in San Antonio, TX. The Oncology Nursing Society’s assignment of meeting space does not imply product endorsement.

    Program Schedule — Central Time

    11:45 AM – 12:15 PM — Registration and Lunch
    12:15 PM – 1:45 PM — Educational Meeting

    MODULE 1: Identification of Appropriate Candidates with Hormone Receptor (HR)-Positive Metastatic Breast Cancer (mBC) for Agents Targeting the PI3K/AKT/mTOR Pathway

    • Incidence of relevant biomarkers, including alterations along the PI3K/AKT/mTOR pathway, in HR-positive, HER2-negative mBC
    • Clinical characteristics associated with PI3K/AKT/mTOR pathway alterations in HR-positive, HER2-negative mBC
    • Optimal methodology for and timing of assessment for alterations along the PI3K/AKT/mTOR pathway for HR-positive, HER2-negative mBC
    • Role of oncology nurses in facilitating biomarker testing for HR-positive, HER2-negative mBC and helping patients understand the implications of the results

    MODULE 2: Role of Inavolisib in the Management of HR-Positive mBC

    • Mechanistic similarities and differences between inavolisib and earlier-generation PI3K inhibitors (ie, alpelisib); implications for efficacy and tolerability
    • Key findings with inavolisib in combination with palbociclib and fulvestrant as first-line therapy for patients with endocrine-resistant, PIK3CA-mutated, 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 evaluation of inavolisib for endocrine-sensitive, PIK3CA-mutated, HR-positive, HER2-negative mBC; potential role in this setting

    MODULE 3: Adverse Events (AEs) Associated with Inavolisib

    • Incidence of hyperglycemia with inavolisib; optimal monitoring of fasting glucose levels and HbA1c
    • Appropriate management of hyperglycemia occurring with inavolisib; indications for antidiabetic medications and dose modifications
    • Incidence of gastrointestinal (GI) toxicities (eg, diarrhea, stomatitis, nausea) with inavolisib; strategies for mitigation and management
    • Spectrum, frequency, severity and management of other toxicities (eg, cytopenias, fatigue, rash) documented with inavolisib-containing therapy

    MODULE 4: Clinical Utility of Capivasertib in the Management of HR-Positive mBC

    • Biological rationale for inhibiting AKT in the management of HR-positive mBC; mechanism of action of capivasertib
    • Key efficacy and safety data with capivasertib/fulvestrant for recurrent HR-positive, HER2-negative mBC
    • FDA approval of capivasertib for patients with HR-positive, HER2-negative mBC with PIK3CA/AKT1/PTEN alterations, and current role opposite other evidence-based options
    • Ongoing evaluation of the triplet combination of capivasertib, fulvestrant and a CDK4/6 inhibitor as first-line therapy for patients with HR-positive, HER2-negative mBC who experience disease progression on or within 12 months of completing (neo)adjuvant endocrine therapy

    MODULE 5: Side Effects and Other Practical Considerations with Capivasertib

    • Recommended management strategies for patients experiencing diarrhea and other GI disorders while receiving capivasertib
    • Pathophysiology, spectrum and optimal treatment of cutaneous adverse reactions with capivasertib
    • Incidence of hyperglycemia in patients receiving capivasertib; indications for blood glucose monitoring and role, if any, for patients with preexisting diabetes
    • Dose, schedule and recommended approach to dose modifications with capivasertib

    MODULE 6: Potential Role of Gedatolisib in the Management of HR-Positive mBC

    • Mechanistic similarities and differences between gedatolisib and currently approved therapies targeting the PI3K/AKT/mTOR pathway for HR-positive mBC; implications for antitumor activity
    • Recently presented data from the PIK3CA wild-type cohort of a Phase III study evaluating gedatolisib in combination with fulvestrant with or without palbociclib for patients with HR-positive, HER2-negative mBC whose disease progressed on or after prior CDK4/6 inhibitor therapy and an aromatase inhibitor
    • Anticipated read-out of the PIK3CA-mutated cohort of the aforementioned study
    • Potential role of gedatolisib-containing combination therapy for pretreated HR-positive, HER2-negative mBC that is PIK3CA wild type and PIK3CA mutated

    MODULE 7: Tolerability Profile of Gedatolisib

    • Rates of treatment discontinuation due to an AE documented with gedatolisib/palbociclib/fulvestrant and gedatolisib/fulvestrant
    • Incidence and severity of hyperglycemia and diarrhea with gedatolisib-based therapy relative to other agents targeting the PI3K/AKT/mTOR pathway
    • Spectrum and incidence of other treatment-related AEs documented with gedatolisib-based therapy (eg, stomatitis, neutropenia, nausea, vomiting, rash, fatigue)
    • Strategies to monitor for, mitigate and manage treatment-related AEs with gedatolisib

    Target Audience
    This activity has been designed to meet the educational needs of oncology nurses, nurse practitioners and clinical nurse specialists involved in the treatment of breast cancer.

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

    • Review available research documenting the correlation between various biomarkers, such as PIK3CA/AKT1/PTEN alterations and ESR1 mutations, and response to specific therapies, and understand optimal testing algorithms for patients with hormone receptor (HR)-positive metastatic breast cancer (mBC).
    • Recognize the frequency of PIK3CA/AKT/PTEN alterations in HR-positive mBC, and educate patients with newly diagnosed and relapsed/refractory disease about evidence-based approaches to targeting these aberrations.
    • 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.
    • Assess the spectrum, frequency and severity of adverse events associated with available and emerging agents targeting the PI3K/AKT/mTOR pathway, and consider recommended approaches to prevent, ameliorate and manage these side effects.
    • Evaluate available research findings with and ongoing studies evaluating novel PI3K/AKT/mTOR inhibitor-based approaches, and consider the potential role of these strategies.

    Accreditation Statement
    Research To Practice is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

    Credit Designation Statements
    This educational activity for 1.5 contact hours is provided by Research To Practice.

    This activity is awarded 1.5 ANCC pharmacotherapeutic contact hours.

    Oncology Nursing Certification Corporation (ONCC)/Individual Learning Needs Assessment (ILNA) Certification Information
    The program content has been reviewed by the Oncology Nursing Certification Corporation (ONCC) and is acceptable for recertification points. To review certification qualifications please visit https://researchtopractice.com/Meetings/ONS2026/PI3KAKTmTORMetastaticBreastCancer/ILNA.

    ONCC review is only for designating content to be used for recertification points and is not for NCPD accreditation. NCPD programs must be formally approved for contact hours by an acceptable accreditor/approver of nursing CE to be used for recertification by ONCC. If the NCPD provider fails to obtain formal approval to award contact hours by an acceptable accrediting/approval body, no information related to ONCC recertification or ILNA categories may be used in relation to the program.

    Credit Form
    To obtain a certificate of completion and receive credit for this event, nurses must attend the entire activity and return a completed Educational Assessment and Credit Form. A credit form link will be given to each participant as part of the meeting course materials.

    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
    There is no implied or real endorsement of any product by Research To Practice or the American Nurses Credentialing Center.

    Content Validation and Disclosures
    Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art 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 reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Faculty disclosures will be provided.

    FACULTYMs Fischer has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

    Dr Basho — Advisory Committees: AstraZeneca Pharmaceuticals LP, Celcuity, Novartis, Pfizer Inc; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Celcuity, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Pfizer Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Genentech, a member of the Roche Group, Scorpion Therapeutics; Data and Safety Monitoring Boards/Committees: Pfizer Inc; Speakers Bureaus: DAVA Oncology, MDOutlook; Nonrelevant Financial Relationships: Community Health Media, OncLive, Targeted Oncology. Ms RikalAdvisory Committees: Stemline Therapeutics Inc; Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc. Additional faculty to be announced.

    MODERATORDr Wander Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio Inc, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, Stemline Therapeutics Inc.

    RESEARCH TO PRACTICE NCPD 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.

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

    Meeting Room
    Grand Ballroom A-F (Third Floor)

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

     

    Registration is now closed.

    Investigators Discuss the Optimal Role of Endocrine-Based and Other Strategies in the Management of HR-Positive Breast Cancer

    Accreditation types: 2.25 ABIM MOC, ABS MOC, CME

    Expires: January 2027

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    Faculty

    Angela DeMichele

    Faculty

    Angela DeMichele

    MD, MSCE

    Abramson Cancer Center, Philadelphia, Pennsylvania

    Mariann T and Robert J MacDonald Professor in Breast Cancer, Director, Clinical/Translational Research, Solid Tumor Oncology, Hematology/Oncology Division, Co-Leader, Breast Cancer Program

    Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

    Co-Director, 2-PREVENT Breast Cancer Translational Center of Excellence, Senior Scholar, Center for Clinical Epidemiology and Biostatistics

    Komal Jhaveri

    Faculty

    Komal Jhaveri

    MD, FACP

    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, Clinical Director, Early Drug Development Service, Department of Medicine

    Weill Cornell College of Medicine, New York, New York

    Associate Professor 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

    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

    Seth Wander

    Faculty

    Seth Wander

    MD, PhD

    Massachusetts General Hospital, Boston, Massachusetts

    Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

    Harvard Medical School, Boston, Massachusetts

    Assistant 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 available research establishing the utility of various genomic assays in personalizing adjuvant systemic therapy for hormone receptor (HR)-positive, HER2-negative breast cancer, and identify patients for whom testing would be clinically useful.
    • Consider available clinical trial findings with CDK4/6 inhibitors for localized HR-positive, HER2-negative breast cancer, and identify patients for whom adjuvant treatment with one of these agents may be appropriate.
    • 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 HR-positive metastatic breast cancer (mBC).
    • Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for patients with HR-positive mBC to appropriately counsel patients regarding the optimal use of these agents.
    • Interrogate published research documenting the efficacy of oral selective estrogen receptor degraders for HR-positive, HER2-negative mBC progressing on endocrine therapy in combination with a CDK4/6 inhibitor in order to optimally integrate these agents into the care of appropriately selected patients.
    • Recognize the frequency of PIK3CA/AKT1/PTEN abnormalities in HR-positive mBC, and employ evidence-based approaches designed to target these aberrations for patients with newly diagnosed and relapsed/refractory disease.
    • Consider the spectrum, frequency and severity of adverse events associated with various endocrine-based treatment approaches for HR-positive breast cancer, and appreciate strategies to prevent, ameliorate and manage these side effects.
    • Recall the design of ongoing clinical trials evaluating novel endocrine-based strategies for HR-positive breast cancer, and appropriately counsel patients about availability and participation.

    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 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 these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.25 (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
    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/SanAntonioHRPosBC25/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:

    Angela DeMichele, MD, MSCE
    Mariann T and Robert J MacDonald Professor in Breast Cancer
    Director, Clinical/Translational Research, Solid Tumor Oncology, Hematology/Oncology Division
    Co-Leader, Breast Cancer Program
    Abramson Cancer Center
    Co-Director, 2-PREVENT Breast Cancer Translational Center of Excellence
    Senior Scholar, Center for Clinical Epidemiology and Biostatistics
    Perelman School of Medicine
    University of Pennsylvania
    Philadelphia, Pennsylvania

    Consulting Agreements: Pfizer Inc; Contracted Research: Genentech, a member of the Roche Group, NeoGenomics, Novartis, Pfizer Inc.

    Komal Jhaveri, MD, FACP, FASCO
    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
    Clinical Director, Early Drug Development Service
    Department of Medicine
    Memorial Sloan Kettering Cancer Center
    Associate Professor of Medicine
    Weill Cornell College of Medicine
    New York, New York

    Consultant/Advisory Board Roles: Arvinas, AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Blueprint Medicines, 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, Novartis, Olema Oncology, Pfizer Inc, RayzeBio Inc, Scorpion Therapeutics, Stemline Therapeutics Inc, Zymeworks Inc; Research Funding Support to the Institution: AstraZeneca Pharmaceuticals LP, 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 Inc, Scorpion Therapeutics, Zymeworks Inc.

    Erica Mayer, MD, MPH, FASCO
    Director of Breast Cancer Clinical Research
    Breast Oncology Center
    Dana-Farber Cancer Institute
    Associate Professor of Medicine
    Harvard Medical School
    Boston, Massachusetts

    Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis.

    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.

    Seth Wander, MD, PhD
    Director of Precision Medicine
    Termeer Center for Targeted Therapies
    Director of Translational Research
    Breast Oncology Program
    Massachusetts General Hospital
    Assistant Professor of Medicine
    Harvard Medical School
    Boston, Massachusetts

    Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio Inc, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, 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, 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 Agendia Inc, Biotheranostics Inc, A Hologic Company, Celcuity, Exact Sciences Corporation, Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics Inc.

    Release date: January 2026
    Expiration date: January 2027

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

    Dr DeMichele

    Andre F et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol 2022;40(16):1816-37. Abstract

    Buus R et al. Molecular drivers of Oncotype DX, Prosigna, EndoPredict, and the Breast Cancer Index: A TransATAC study. J Clin Oncol 2021;39(2):126-35. Abstract

    Cardoso F et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016;375(8):717-29. Abstract

    Chen N et al. Impact of anthracyclines in genomic high-risk, node-negative, HR-positive/HER2-negative breast cancer. Ann Oncol 2025;36(11):1356-65. Abstract

    Kalinsky K et al. 21-Gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med 2021;385(25):2336-47. Abstract

    Nguyen B et al. Comparison of molecular subtyping with BluePrint, MammaPrint, and TargetPrint to local clinical subtyping in breast cancer patients. Ann Surg Oncol 2012;19(10):3257-63. Abstract

    Pan H et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017;377(19):1836-46. Abstract

    Piccart M et al. 70-gene signature as an aid for treatment decisions in early breast cancer: Updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol 2021;22(4):476-88. Abstract

    Pusztai L et al. Development and validation of the RSClinN+ tool to predict prognosis and chemotherapy benefit for hormone receptor–positive, node-positive breast cancer. J Clin Oncol 2025;43(8):919-28. Abstract

    Sestak I et al. Comparison of the performance of 6 prognostic signatures for estrogen receptor-positive breast cancer: A secondary analysis of a randomized clinical trial. JAMA Oncol 2018;4(4):545-53. Abstract

    Sgroi DC et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. J Natl Cancer Inst 2013;105(14):1036-42. Abstract

    Sparano JA et al. Trial assigning individualized options for treatment (TAILORx): An update including 12-year event rates. San Antonio Breast Cancer Symposium 2022;Abstract GS1-05.

    Sparano JA et al. Development and validation of a tool integrating the 21-gene recurrence score and clinical-pathological features to individualize prognosis and prediction of chemotherapy benefit in early breast cancer. J Clin Oncol 2021;39(6):557-64. Abstract

    Sparano JA et al. Clinical outcomes in early breast cancer with a high 21-gene recurrence score of 26 to 100 assigned to adjuvant chemotherapy plus endocrine therapy: A secondary analysis of the TAILORx randomized clinical trial. JAMA Oncol 2020;6(3):367-74. Abstract

    Woolpert KM et al. Biomarkers predictive of a response to extended endocrine therapy in breast cancer: A systematic review and meta-analysis. Breast Cancer Res Treat 2024;203(3):407-17. Abstract

    Dr Jhaveri

    Barrios CH et al. NATALEE update: Safety and treatment (tx) duration of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC). ESMO Breast 2024;Abstract 113MO.

    Cortes J et al. monarchE: Subgroup analysis of adjuvant abemaciclib + endocrine therapy for HR+, HER2-, high-risk early breast cancer by nodal status. San Antonio Breast Cancer Symposium 2025;Abstract PS1-08-08.

    Crown J et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. ESMO Open. 2025;10(11). Abstract

    Fasching PA et al. Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2− early breast cancer (EBC). ESMO Virtual Plenary 2023;Abstract VP3-2023.

    Hamilton EP et al. Efficacy and safety results by age in monarchE: Adjuvant abemaciclib combined with endocrine therapy (ET) in patients with HR+, HER2-, node-positive, high-risk early breast cancer (EBC). ASCO 2023;Abstract 501.

    Harbeck N et al. Adjuvant abemaciclib plus endocrine therapy for HR+, HER2-, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. ESMO 2023;Abstract LBA17.

    Hortobagyi G et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: Final invasive disease–free survival (iDFS) analysis from the NATALEE trial. San Antonio Breast Cancer Symposium 2023;Abstract GS03-03.

    Hurvitz S et al. Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC). San Antonio Breast Cancer Symposium 2025;Abstract PS3-09-08.

    Jhaveri K et al. Real-world evidence on risk of recurrence (ROR) in patients (pts) with node-negative (N0) and node-positive HR+/HER2– early breast cancer (EBC) from US electronic health records (EHR). ESMO 2024;Abstract 292P.

    Johnston SRD et al. monarchE: Primary overall survival (OS) results of adjuvant abemaciclib + endocrine therapy (ET) for HR+, HER2-, high-risk early breast cancer (EBC). ESMO 2025;Abstract LBA13.

    Johnston S et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol 2025;[Online ahead of print]. Abstract

    Mayer EL et al. Palbociclib with adjuvant endocrine therapy in early breast cancer: 5-year follow-up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13). Ann Oncol 2025;[Online ahead of print]. Abstract

    O’Shaughnessy J et al. Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer. Breast 2025;81. 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 plus endocrine therapy in early breast cancer. N Engl J Med 2024;390(12):1080-91. Abstract

    Slamon DJ et al. Rationale and trial design of NATALEE: A phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol 2023;15. 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.

    Tolaney SM et al. Real-world risk of recurrence by nodal status in patients with HR+, HER2-, node-positive, high-risk early breast cancer. NCODA 2025;Abstract.

    Tolaney SM et al. Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy as adjuvant therapy for HR+, HER2-, node-positive, high-risk, early breast cancer. Eur J Cancer 2024;199. Abstract

    Dr Rugo

    Bidard FC et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

    Bidard FC et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025; Abstract RF7-03

    de la Haba-Rodriguez J et al. ABIGAIL: Randomized phase II study of abemaciclib plus endocrine therapy (ET) with or without a short course of induction paclitaxel in patients (pts) with previously untreated HR-positive/HER2-negative advanced breast cancer (HR+/HER2- ABC) with aggressive disease criteria. ESMO 2024;Abstract LBA23.

    Dieras V et al. Primary results of Ambre, a randomized phase 3 comparing mono-chemotherapy (ct) vs abemaciclib + endocrine therapy (et) in hr+/her2- advanced breast cancer (abc) with high visceral tumor burden. San Antonio Breast Cancer Symposium 2025;Abstract RF7-06.

    Goetz MP et al. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: Final overall survival results of MONARCH 3. Ann Oncol 2024;35(8):718-27. Abstract

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

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

    Loibl S et al. Primary results of the randomised phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy – PADMA study. San Antonio Breast Cancer Symposium 2024;Abstract LB1-03.

    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

    Mayer E et al. Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC). ESMO 2025;Abstract 486MO.

    Rugo HS et al. Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2− metastatic breast cancer in the US real-world setting. ESMO Open 2025;10(1). Abstract

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

    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. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

    Dr Mayer

    Hurvitz SA et al. Gedatolisib (geda) + fulvestrant ± palbociclib (palbo) vs fulvestrant in patients (pts) with HR+/ HER2-/PIK3CA wild-type (WT) advanced breast cancer (ABC): First results from VIKTORIA-1. ESMO 2025;Abstract LBA17.

    Rosetti S et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer 2024;10(1):40. 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. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

    Dr Wander

    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):4299-409. Abstract

    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

    Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

    Jeselsohn R et al. ESR1 mutations—A mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol 2015;12(10):573-83. Abstract

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

    Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2025;[Online ahead of print]. Abstract

    Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

    Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2−, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2025;[Online ahead of print]. Abstract

    Teysir J et al. After a CDK4/6 inhibitor: State of the art in hormone receptor–positive metastatic breast cancer. Am Soc Clin Oncol Educ Book 2025;45(3):e473372. Abstract

    Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

    Urso L et al. ESR1 gene mutation in hormone receptor-positive HER2-negative metastatic breast cancer patients: Concordance between tumor tissue and circulating tumor DNA analysis. Front Oncol 2021;11. Abstract

    Vasan N et al. Concordance between tissue (tumor DNA) and liquid (ctDNA) biopsy next-generation sequencing (NGS) data in detection of PIK3CA, AKT1, and PTEN alterations in breast cancer: A retrospective analysis. ASCO 2024;Abstract e153033.

    Clinical Investigators Review the Current and Future Role of Oral SERDs in the Care of Patients with ER-Positive Metastatic Breast Cancer

    Accreditation types: 2.75 ABIM MOC, ABS MOC, CME

    Expires: October 2026

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    Faculty

    Francois-Clement Bidard

    Faculty

    Francois-Clement Bidard

    MD, PhD

    Institut Curie, Paris, France

    Professor of Medical Oncology

    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

    Rebecca Shatsky

    Faculty

    Rebecca Shatsky

    MD

    University of California San Diego, Moores Cancer Center, San Diego, California

    Professor of Clinical Medicine, Breast Medical Oncology Team Leader, Director of Breast Cancer Clinical Trials, Director of Inflammatory and Triple Negative Breast Cancer Program

    Seth Wander

    Faculty

    Seth Wander

    MD, PhD

    Massachusetts General Hospital, Boston, Massachusetts

    Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

    Harvard Medical School, Boston, Massachusetts

    Assistant Professor 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

    • Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer, 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 available and investigational oral SERDs for ESR1-mutated ER-positive, HER2-negative metastatic breast cancer progressing on standard endocrine therapy with a CDK4/6 inhibitor in order to optimally integrate these agents into patient care.
    • Evaluate available clinical trial data with oral SERDs in combination with other therapeutic agents for patients with and without ESR1 mutations, and consider the potential role of these regimens.
    • Appreciate the side effects associated with available and investigational oral SERDs, and use this information to develop supportive management plans for patients undergoing treatment with this form of therapy.
    • Assess ongoing clinical research evaluating novel applications of oral SERDs for ER-positive breast cancer, and counsel patients regarding the potential benefits of trial participation.

    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 Interview: Research To Practice designates this enduring material for a maximum of 2.75 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 2.75 (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
    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/OralSERDsmBCThinkTank2025/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:

    Francois-Clement Bidard, MD, PhD
    Professor of Medical Oncology
    Institut Curie
    Paris, France

    Advisory Committees: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Foresight Diagnostics, Inatherys, Lilly, Menarini Silicon Biosystems, Novartis, Pfizer Inc, Roche Laboratories Inc, SAGA Diagnostics; Congress Attendance Support: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Novartis, Pfizer Inc, Roche Laboratories Inc; Contracted Research: GE Healthcare, Menarini Silicon Biosystems, Merck KGaA, MSD, Novartis, Personalis, Pfizer Inc, ProLynx Inc, Roche Laboratories Inc, SAGA Diagnostics, Tempus; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Lilly, Novartis, Roche Laboratories Inc.

    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: Bristol Myers Squibb, Chugai Pharmaceutical Co Ltd, Napo Pharmaceuticals Inc, Sanofi; Contracted Research (Institutional Research Support): Ambrx, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Merck, Novartis, OBI Pharma Inc, Pfizer Inc, Stemline Therapeutics Inc.

    Rebecca Shatsky, MD
    Professor of Clinical Medicine
    Breast Medical Oncology Team Leader
    Director of Breast Cancer Clinical Trials
    Director of Inflammatory and Triple Negative Breast Cancer Program
    University of California San Diego
    Moores Cancer Center
    San Diego, California

    Advisory Committees: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Merck, Novartis, Pfizer Inc, Stemline Therapeutics Inc; Consulting Agreements: Daiichi Sankyo Inc; Contracted Research: Institutional funding (principal investigator for trials) — Alterome Therapeutics, AstraZeneca Pharmaceuticals LP, BriaCell, Gilead Sciences Inc, Hummingbird Bioscience, Jazz Pharmaceuticals Inc, Mabwell Therapeutics Inc, OBI Pharma Inc, OnKure Therapeutics, Regor Therapeutics, Stemline Therapeutics Inc.

    Seth Wander, MD, PhD
    Director of Precision Medicine
    Termeer Center for Targeted Therapies
    Director of Translational Research
    Breast Oncology Program
    Massachusetts General Hospital
    Assistant Professor of Medicine
    Harvard Medical School
    Boston, Massachusetts

    Consulting Agreements: Arvinas, AstraZeneca Pharmaceuticals LP, Biovica International AB, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, Hologic Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Arvinas, Genentech, a member of the Roche Group, Lilly, Menarini Group, Nuvation Bio, Pfizer Inc, Phoenix Molecular Designs, Puma Biotechnology Inc, Regor Therapeutics, Sermonix Pharmaceuticals, 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, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, 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, 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 and Stemline Therapeutics Inc.

    Release date: October 2025
    Expiration date: October 2026

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

    Dr Shatsky

    Allouchery V et al. Circulating ESR1 mutations at the end of aromatase inhibitor adjuvant treatment and after relapse in breast cancer patients. Breast Cancer Res 2018;20(1):40. Abstract

    Benvenuti C et al. Unveiling the potential of cyclin-dependent kinases 4 and 6 inhibitors beyond progression in hormone receptor positive/human epidermal growth factor negative advanced breast cancer — A clinical review. Curr Treat Options Oncol 2024;25(12):1517-137. Abstract

    Bielo LB et al. Genomic and clinical landscape of metastatic hormone receptors-positive breast cancers carrying ESR1 alterations. ESMO Open 2024;9(10):103731. Abstract

    Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. Abstract

    Burstein HJ et al. Testing for ESR1 mutations to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline Rapid Recommendations Update. J Clin Oncol 2023;41(18):3423-5. Abstract

    Chandarlapaty S et al. Prevalence of ESR1 mutations in cell-free DNA and outcomes in metastatic breast cancer: A secondary analysis of the BOLERO-2 clinical trial. JAMA Oncol 2016;2(10):1310-5. 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

    Jeselsohn R et al. Allele-specific chromatin recruitment and therapeutic vulnerabilities of ESR1 activating mutations. Cancer Cell 2018;33(2):173-86.e5. Abstract

    Neupane N et al. Oral SERD, a novel endocrine therapy for estrogen receptor-positive breast cancer. Cancers (Basel) 2024;16(3):619. Abstract

    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

    Toy W et al. Activating ESR1 mutations differentially affect the efficacy of ER antagonists. Cancer Discov 2017;7(3):277-87. Abstract

    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 trials. Clin Cancer Res 2020;26(19):5172-7. Abstract

     

    Dr Wander

    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

    Bidard F-C et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

    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

    Guglielmi G et al. Pharmacological insights on novel oral selective estrogen receptor degraders in breast cancer. Eur J Pharmacol 2024;969:176424. Abstract

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

    Lloyd M et al. Impact of prior treatment, ESR1 mutational (ESR1m) landscape, and co-occurring PI3K pathway status on real-world (RW) elacestrant outcomes in patients (pts) with hormone receptor-positive (HR+)/HER2-negative advanced breast cancer (aBC). San Antonio Breast Cancer Symposium 2024;Abstract PS7-05.

    Martin 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.

    Patel R et al. An emerging generation of endocrine therapies in breast cancer: A clinical perspective. NPJ Breast Cancer 2023;9(1):20. Abstract

    Teysir J et al. After a CDK4/6 inhibitor: State of the art in hormone receptor-positive metastatic breast cancer. Am Soc Clin Oncol Educ Book 2025;45(3):e473372. 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

    Toy W et al. Activating ESR1 mutations differentially affect the efficacy of ER antagonists. Cancer Discov 2017;7(3):277-87. Abstract

    Turner N et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol 2023;19(8):559-73. Abstract

     

    Prof Bidard

    Baird RD et al. Camizestrant in combination with three globally approved CDK4/6 inhibitors in women with ER+, HER2− advanced breast cancer: Results from SERENA-1. Clin Cancer Res 2025;[Online ahead of print]. Abstract

    Bidard F-C et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. 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

    Rugo HS et al. Elacestrant in various combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (adv/mBC): Preliminary data from ELEVATE, a phase 1b/2, open-label, umbrella study. ASCO 2024;Abstract 1069.

     

    Dr Rugo

    Bidard F-C et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med 2025;393(6):569-80. Abstract

    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

    Campone M et al. Vepdegestrant, a PROTAC estrogen receptor degrader, in advanced breast cancer. N Engl J Med 2025;393(6):556-8. Abstract

    Chan N et al. Elacestrant combinations in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Safety update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. ASCO 2025;Abstract 1079.

    Cortés J et al. EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2− advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy. ESMO Breast 2023;Abstract 188O.

    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.

    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.

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

    Kaklamani VG et al. Oral elacestrant vs standard-of-care in estrogen receptor-positive, HER2-negative (ER+/HER2-) advanced or metastatic breast cancer (mBC) without detectable ESR1 mutation (EMERALD): Subgroup analysis by prior duration of CDK4/6i plus endocrine therapy (ET). ASCO 2023;Abstract 1070.

    Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. 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 HS et al. Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. ASCO 2025;Abstract 1070.

    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.

    Understanding the Current Paradigm and New Approaches in the Care of Patients with Hormone Receptor-Positive Breast Cancer

    Accreditation types: 2.25 NCPD

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    Faculty

    Virginia F Borges

    Faculty

    Virginia F Borges

    MD, MMSc

    University of Colorado Anschutz Medical Campus, Aurora, Colorado

    Professor of Medicine with Tenure, Robert F and Patricia Young Connor Endowed Chair in Young Women’s Breast Cancer Research, Deputy Division Head, Medical Oncology, Co-Director, Diane O’Connor Thompson Breast Center, Co-Director, Breast Cancer Research Program, Director, Young Women’s Breast Cancer Translational Program

    Jamie Carroll

    Faculty

    Jamie Carroll

    APRN, MSN, CNP

    Mayo Clinic, Rochester, Minnesota

    Assistant Professor, Oncology

    Ronald Stein

    Faculty

    Ronald Stein

    JD, MSN, NP-C, AOCNP

    USC Norris Comprehensive Cancer Center, Los Angeles, California

    Clinical Instructor of Medicine

    Seth Wander

    Faculty

    Seth Wander

    MD, PhD

    Massachusetts General Hospital, Boston, Massachusetts

    Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program

    Harvard Medical School, Boston, Massachusetts

    Assistant Professor of Medicine

    TARGET AUDIENCE
    This activity has been designed to meet the educational needs of oncology nurses, nurse practitioners and clinical nurse specialists involved in the treatment of breast cancer.

    PURPOSE STATEMENT
    By providing information on the latest research developments in the context of expert perspectives, this NCPD activity will assist oncology nurses, nurse practitioners and clinical nurse specialists with the formulation of state-of-the-art clinical management strategies to facilitate optimal care of patients with 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.
    • Appraise published efficacy and safety data from randomized clinical trials evaluating CDK4/6 inhibitors for HR-positive metastatic breast cancer (mBC) in order to appropriately counsel patients regarding the optimal clinical use of these agents.
    • Review available research documenting the correlation between the presence of various biomarkers (eg, PIK3CA/AKT1/PTEN alterations, ESR1 mutations) and response to specific therapies in patients with HR-positive mBC.
    • Recall the frequency of phosphoinositide-3 kinase pathway mutations in patients with HR-positive mBC, and recognize the evidence-based approaches available to target these aberrations in individuals with PIK3CA-mutated disease.
    • Interrogate published Phase III research documenting the efficacy of AKT inhibitors for progressive HR-positive mBC to determine the current clinical applicability of this approach.
    • Understand the mechanism of action of, published and emerging research findings with and the current and future clinical role of oral selective estrogen receptor degraders for patients with HR-positive mBC harboring ESR1 mutations.
    • Discern the side effects and toxicities associated with available and investigational endocrine-based therapies for breast cancer, and identify strategies to manage and mitigate them.

    ACCREDITATION STATEMENT
    Research To Practice (RTP) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

    CREDIT DESIGNATION STATEMENT
    Video Program: This educational activity for 2.25 contact hours is provided by RTP during the period of May 2025 to May 2026.

    This activity is awarded 2.25 ANCC pharmacotherapeutic contact hours.

    ONCC/ILNA CERTIFICATION INFORMATION
    The program content has been reviewed by the ONCC and is acceptable for recertification points. Learners must apply for NCPD credit to utilize this program for ONCC certification or renewal. To review certification qualifications please visit https://www.researchtopractice.com/Meetings/ONS2025/HRPositiveBreastCancer/ILNA.

    ONCC review is only for designating content to be used for ILNA points and is not for NCPD accreditation. NCPD programs must be formally approved for contact hours by an acceptable accreditor/approver of nursing CE to be used for recertification by ONCC. If the NCPD provider fails to obtain formal approval to award contact hours by an acceptable accrediting/approval body, no information related to ONCC recertification or ILNA categories may be used in relation to the program.

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    FOR SUCCESSFUL COMPLETION
    Video Program: This NCPD activity consists of a video component. To receive credit, the participant should review the NCPD information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ONS2025/HRPosBC/Video/NCPD.

    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:

    Virginia F Borges, MD, MMSc
    Professor of Medicine with Tenure
    Robert F and Patricia Young-Connor Endowed Chair in Young Women’s Breast Cancer Research
    Deputy Head, Division of Medical Oncology
    Director, Breast Cancer Research Program and
    Young Women’s Breast Cancer Translational Program
    University of Colorado Cancer Center
    Aurora, Colorado

    Advisory Committees: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Olema Oncology, Pfizer Inc, Seagen Inc; Consulting Agreements: Gilead Sciences Inc, Olema Oncology; Contracted Research: Agendia Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Gilead Sciences Inc, Olema Oncology, Pfizer Inc, Seagen Inc; Data and Safety Monitoring Boards/Committees: Pfizer Inc, Seagen Inc (HER2CLIMB-02 trial); Nonrelevant Financial Relationships: Pearl Scientific LLC.

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

    Advisory Committees: AstraZeneca Pharmaceuticals LP, Lilly, Merck, Novartis; Nonrelevant Financial Relationships: Clinical Care Options, Horizon CME, MJH Life Sciences, OncLive, Scientific Global.

    Ronald Stein, JD, MSN, NP-C, AOCNP
    Clinical Instructor of Medicine
    USC Norris Comprehensive Cancer Center
    Los Angeles, California

    Advisory Committees: Biotheranostics Inc; Consulting Agreements: AstraZeneca Pharmaceuticals LP.

    Seth Wander, MD, PhD
    Assistant Professor of Medicine
    Harvard Medical School
    Attending Physician
    Massachusetts General Hospital
    Boston, Massachusetts

    Advisory Committees: Biovica International AB, Genentech, a member of the Roche Group, Hologic Inc, Pfizer Inc, Puma Biotechnology Inc, Regor Therapeutics Group; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Foundation Medicine, Lilly, Novartis; Contracted Research: Genentech, a member of the Roche Group, Lilly, Nuvation Bio, Pfizer Inc, Regor Therapeutics Group, Sermonix Pharmaceuticals; Data and Safety Monitoring Boards/Committees: Regor Therapeutics Group; Speakers Bureaus: Guardant Health, Lilly; Nonrelevant Financial Relationship: 2nd.MD.

    MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop NCPD 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 NCPD 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, Genentech, a member of the Roche Group, Novartis, and Stemline Therapeutics Inc.

    Release date: May 2025
    Expiration date: May 2026

    There is no implied or real endorsement of any product by RTP or the American Nurses Credentialing Center.

    Dr Borges

    Module 1: Role of CDK4/6 Inhibitors in Localized and Metastatic Hormone Receptor (HR)-Positive Breast Cancer

    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.

    Harbeck N et al. Adjuvant abemaciclib plus endocrine therapy for HR+, HER2-, high-risk early breast cancer: Results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. ESMO 2023;Abstract LBA17.

    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. Clin Oncol 2024;42(23):2812-21. 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

    Tarantino P et al. Quantitative standardized high sensitivity (HS)-HER2 testing predicts outcomes with trastuzumab deruxtecan (T-DXd) for metastatic breast cancer (MBC). ESMO 2024;Abstract 394P. Abstract

     

    Module 3: Clinical Utility of AKT and PI3K Inhibitors in Progressive HR-Positive mBC

    Armaghani AJ, Han HS. Alpelisib in the treatment of breast cancer: A short review on the emerging clinical data. Breast Cancer (Dove Med Press) 2020;12:251-8. Abstract

    Borges VF. Options for endocrine-refractory, hormone receptor–positive breast cancer: Which target and when? J Clin Oncol 2021;39(35):3890-6. Abstract

    Cerma K et al. Targeting PI3K/AKT/mTOR pathway in breast cancer: From biology to clinical challenges. Biomedicines 2023;11(1):109. Abstract

    Schlam I, Chavez-MacGregor M. Best of the year: Advanced breast cancer in 2023. Breast 2024;74:103677. Abstract

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

     

    Dr Wander

    Module 2: PI3K Inhibition as First-Line Treatment for HR-Positive, HER2-Negative Metastatic Breast Cancer (mBC)

    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-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract

    Brett JO et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res 2021;23(1):85. 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.

    Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract

    Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract

    Urso L et al. ESR1 gene mutation in hormone receptor-positive HER2-negative metastatic breast cancer patients: Concordance between tumor tissue and circulating tumor DNA analysis. Front Oncol 2021;11:625636. Abstract

    Vasan N et al. Concordance between tissue (tumor DNA) and liquid (ctDNA) biopsy next-generation sequencing (NGS) data in detection of PIK3CA, AKT1, and PTEN alterations in breast cancer: A retrospective analysis. ASCO 2024;Abstract e15033.

    Vasan N, Cantley LC. At a crossroads: How to translate the roles of PI3K in oncogenic and metabolic signalling into improvements in cancer therapy. Nat Rev Clin Oncol 2022;19(7):471-85. Abstract

     

    Module 4: Current and Future Role of Oral Selective Estrogen Receptor Degraders in HR-Positive mBC

    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. GS3-01 EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. San Antonio Breast Cancer Symposium 2022;Abstract GS3-01.

    Bardia A et al. EMERALD: A randomized, open label, phase III trial to evaluate the efficacy and safety of elacestrant (RAD1901) versus investigator’s choice (IC) of endocrine therapy (ET) for ER+/HER2- advanced breast cancer (BC) following CDK4/6 inhibitor (CDK4/6i) therapy. ASCO 2019;Abstract TPS1104.

    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

    Jeselsohn R et al. ESR1 mutations—A mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol 2015;12(10):573-83. Abstract

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

    Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract

    Patel R et al. An emerging generation of endocrine therapies in breast cancer: A clinical perspective. NPJ Breast Cancer 2023;9(1):20. Abstract

    Turner N et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol 2023;19(8):559-73. Abstract

    • for-nurses