Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies 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
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

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

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

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

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

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

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer 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.

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

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

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

This activity is supported by educational grants from Genentech, a member of the Roche Group, 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.

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;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. 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.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

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.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

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

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies 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
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

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

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

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

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

HOW TO USE THIS CME ACTIVITY

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

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

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

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer 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.

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

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

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

This activity is supported by educational grants from Genentech, a member of the Roche Group, 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.

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;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. 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.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

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.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

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

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies 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
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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

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

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

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

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

HOW TO USE THIS CME ACTIVITY

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

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

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

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer 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.

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

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

This educational activity contains 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.

This activity is supported by educational grants from Genentech, a member of the Roche Group, 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.

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;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. 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.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

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.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

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

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

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

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Dr Wander

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