Second Opinion: A Case-Based Exploration of Clinical Investigator Best Practices Related to the Management of Localized HR-Positive Breast Cancer

Faculty

Adam M Brufsky

MD, PhD

UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania

Professor of Medicine, Department of Medicine

Moderator

Rita Nanda

MD

The University of Chicago, Chicago, Illinois

Director, Breast Oncology, Associate Professor of Medicine, Section of Hematology/Oncology

Additional faculty to be announced.

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

Integration of Adjuvant CDK4/6 Inhibitor Therapy into the Current Management of High-Risk, Hormone Receptor (HR)-Positive, HER2-Negative Localized Breast Cancer 

• Clinical and biological factors (eg, age/menopausal status, tumor size/grade, nodal involvement, genomic assay results, comorbidities) affecting the choice of adjuvant therapy for HR-positive, HER2-negative localized breast cancer; rationale for the addition of CDK4/6 inhibitors to standard adjuvant endocrine therapy for high-risk disease  
• Long-term outcomes, including overall survival (OS) data, from the Phase III monarchE trial evaluat­ing the addition of abemaciclib to standard adju­vant hormonal therapy for patients with high-risk, HR-positive, HER2-negative localized breast cancer 
• Extended follow-up with adjuvant ribociclib and endocrine therapy compared to endocrine therapy alone in the Phase III NATALEE trial  
• FDA-approved indications and identification of appropriate candidates for adjuvant abemaciclib and ribociclib 
• Other relevant studies (eg, the Phase II TRADE trial) attempting to optimize the use of CDK4/6 inhibitors in the adjuvant setting  
• Available data with and ongoing studies evaluating CDK4/6 inhibitors as neoadjuvant therapy for local­ized HR-positive breast cancer 

Available Data with and Practical Application of PARP Inhibition as Adjuvant Therapy for Patients with HR-Positive Localized Breast Cancer 

• Incidence of germline BRCA1/2 mutations and other homologous recombination repair (HRR) gene mutations in patients with HR-positive, HER2-negative breast cancer; optimal approach to genetic testing  
• Key findings, including OS data, from the Phase III OlympiA trial assessing adjuvant olaparib versus pla­cebo for patients with high-risk, HER2-negative breast cancer and germline BRCA1/2 mutations  
• Optimal selection of candidates with high-risk, HR-positive, HER2-negative breast cancer with germline BRCA mutations for adjuvant olaparib; role, if any, for patients with other germline or somatic HRR alterations  
• Early data with and ongoing evaluation of PARP inhibitors in the neoadjuvant setting  
• Incidence, severity and management of toxicities asso­ciated with PARP inhibitors in the localized setting  

Potential Use of Oral Selective Estrogen Receptor Degraders (SERDs) for HR-Positive, HER2-Negative Localized Breast Cancer 

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

Risk Assessment and Genomic Assays for Treatment Decision-Making in HR-Positive, HER2-Negative Localized Breast Cancer  

• Similarities and differences among available genomic assays (eg, Oncotype DX^®, MammaPrint^®, Prosigna^®, EndoPredict^®, Endocrine Activity Index^®, Breast Cancer Index^®)  
• Key studies informing the use of the 21-gene Recurrence Score^® (RS) to guide neoadjuvant and adjuvant treatment decision-making for patients with HR-positive, HER2-negative localized breast cancer 
• Clinical research supporting the utility of the 70-gene signature in preoperative and adjuvant treatment planning for patients with HR-positive, HER2- negative localized breast cancer 
• Current clinical utility of genetic tests and prog­nostic tools that complement available genomic assays (eg, the RSClin educational tool in concert with the 21-gene RS, the BluePrint^® molecular subtyping test in concert with the 70-gene signature)  
• Published research supporting the use of the Breast Cancer Index to inform extended adjuvant endo­crine therapy decision-making for patients with HR-positive localized breast cancer 

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

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

• Understand how various clinical and biological factors, including age/menopausal status, tumor size/grade and nodal involvement affect a patient’s risk of recurrence, and use this information to personalize the selection of adjuvant systemic therapy for individuals with newly diagnosed hormone receptor (HR)-positive, HER2-negative breast cancer. 
• Appraise the scientific justification for, available data with and potential clinical role of oral selective estrogen receptor degraders (SERDs) as adjuvant treatment for localized estrogen recep­tor-positive, HER2-negative breast cancer.  
• Consider available clinical trial findings with CDK4/6 inhibitors for localized HR-positive, HER2-negative breast cancer, and identify patients for whom adjuvant therapy with one of these agents would be appropriate.  
• Recognize adverse events and other common side effects associated with different CDK4/6 inhibitors for localized breast cancer, and tailor therapy for individuals with preexisting medical conditions and relevant comorbidities.  
• Appreciate the incidence of BRCA1/2 and other DNA damage repair mutations in patients with localized HR-positive breast cancer, and assess the role of adjuvant PARP inhibition for individuals harboring these abnormalities.  
• Assess the similarities and differences among the various genomic assays with established prognostic and predictive utility for HR-positive localized breast cancer, and consider available research findings informing the use of these tests. 

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

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

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

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

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

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

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

Dr Brufsky — Consulting Agreements: Agendia Inc, AstraZeneca Pharmaceuticals LP, BriaCell, Celcuity, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc; Contracted Research: Agendia Inc; Stock Options/Stock — Public Companies: Celcuity; Stock Options — Private Companies: Ataraxis. Dr Nanda — Advisory Committees: AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Exact Sciences Corporation, Gilead Sciences Inc, Lilly, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Summit Therapeutics; Contracted Research: Arvinas, AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Mabwell Therapeutics Inc, Merck, Pfizer Inc, Relay Therapeutics. Additional faculty to be announced.

MODERATOR
To be announced.

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

Supporters
This activity is supported by educational grants from Agendia Inc, AstraZeneca Pharmaceuticals LP, Biotheranostics Inc, A Hologic Company, Exact Sciences Corporation, Genentech, a member of the Roche Group, and Merck.

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

Meeting Room
To be announced.

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

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

Registration to attend virtually is open to all professionals.

Please click the link to register for this live event directly on Zoom. Once you register, Zoom will send a confirmation email with your individual link to access the event. Please keep that confirmation email handy. If you do not receive it, contact our support team at meetings@researchtopractice.com.

To ensure seating and meal service, please check in at our onsite registration desk before the start of the meeting. We cannot guarantee seating after the start of the program.

Photography and/or video recording may be taken during the educational program by Research To Practice and used in future educational offerings.

Research To Practice fully complies with the legal requirements of the ADA. If you require any physical, dietary or other accommodations, please call us at (800) 233-6153 before the event.

If you have any questions, please feel free to contact us via email at Meetings@ResearchToPractice.com, or call (800) 233-6153.