Second Opinion: A Case-Based Exploration of Clinical Investigator Best Practices Related to the Management of HER2-Positive Breast Cancer

Faculty

Nadia Harbeck

MD, PhD

LMU University Hospital, Munich, Germany

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

Faculty

Ian E Krop

MD, PhD

Yale Cancer Center, New Haven, Connecticut

Professor of Medicine, Chief of Medical Oncology and Hematology

Moderator

Sara M Tolaney

MD, MPH

Dana-Farber Cancer Institute, Boston, Massachusetts

Chief, Division of Breast Oncology

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

Additional faculty to be announced.

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

Evolving Care Paradigms for Patients with Localized HER2-Positive Breast Cancer 

• Key clinical factors affecting the selection of neoadju­vant and adjuvant systemic therapy for patients with HER2-positive localized breast cancer; outcomes achieved with historical standards of care 
• Published findings from the Phase III DESTINY-Breast11 study evaluating trastuzumab deruxtecan (T-DXd) as a component of neoadjuvant therapy for patients with high-risk, HER2-positive localized breast cancer 
• Key data from the Phase III DESTINY-Breast05 study of T-DXd versus trastuzumab emtansine for high-risk, HER2-positive breast cancer in patients with residual invasive disease after neoadjuvant therapy 
• FDA approvals of T-DXd in the neoadjuvant and adjuvant settings; current clinical role of T-DXd as a component of cura­tive-intent therapy 
• Ongoing clinical research trials evaluating novel HER2-directed approaches for patients with localized HER2-positive breast cancer 

Optimizing First-Line and Maintenance Therapy for HER2-Positive Metastatic Breast Cancer (mBC) 

• Key factors affecting the selection of front-line and maintenance therapy for patients with HER2-positive mBC 
• Published efficacy and safety findings from the Phase III DESTINY-Breast09 trial documenting the benefit of T-DXd in combination with pertuzumab versus taxane/trastuzumab/pertuzumab as first-line therapy for HER2-positive mBC 
• FDA approval of T-DXd/pertuzumab as up-front therapy; optimal integration into practice 
• Key efficacy and safety outcomes from the Phase III HER2CLIMB-05 study assessing tucatinib in combination with standard first-line maintenance therapy after chemotherapy-based induction for HER2-positive mBC 
• Available data from the Phase III PATINA study evaluating the addition of palbociclib to mainte­nance HER2-targeted therapy and endocrine therapy after induction treatment for HR-positive, HER2-positive mBC 
• Optimal selection of up-front maintenance therapy for patients with HR-negative and HR-positive, HER2-positive mBC, including those receiving first-line T-DXd/pertuzumab; ongoing trials (eg, DEMETHER) attempting to further guide this decision 

Selection and Sequencing of Therapy for Relapsed/Refractory HER2-Positive mBC 

• Outcomes documented among patients with previ­ously treated HER2-positive mBC in pivotal clini­cal research studies of T-DXd and tucatinib-based combinations 
• Incidence of central nervous system metasta­ses in patients with HER2-positive mBC, and effect on overall prognosis 
• Intracranial efficacy documented with T-DXd and tucatinib-based therapy in published research efforts 
• Long-term findings with and optimal integra­tion of other evidence-based treatment options for patients with progressive HER2-positive mBC  
• Other promising agents and strategies under inves­tigation for advanced HER2-positive breast cancer 

Identification and Management of Adverse Events (AEs) with T-DXd and Other HER2-Targeted Strategies 

• Spectrum, incidence and severity of common and unique AEs with different HER2-targeted ther­apies employed in the management of HER2- positive breast cancer 
• Recommendations for monitoring and immediate reporting of symptoms of interstitial lung disease (ILD) and cardiac toxicities with T-DXd 
• Strategies to manage T-DXd-associated ILD and cardiac toxicities; indications for restarting T-DXd after resolution of symptoms 
• Recommended algorithms for monitoring for, mit­igating and managing cytopenias, gastrointestinal side effects and other complications of T-DXd and other HER2-targeted therapies 
• Differences, if any, in the tolerability/toxicity profile of T-DXd in the (neo)adjuvant versus first-line met­astatic versus relapsed/refractory settings 

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

• Assess available Phase III data with HER2-directed antibody-drug conjugate (ADC) ther­apy as a component of neoadjuvant therapy for patients with high-risk localized disease, and consider the potential clinical role of this novel treatment approach. 
• Evaluate current research evidence with HER2-directed ADC therapy for patients with HER2-positive localized breast cancer with residual disease after neoadjuvant treatment. 
• Appraise available clinical research data, current guideline recommendations and expert best prac­tices to guide the selection of first-line and maintenance therapy for patients with newly diagnosed HER2-positive metastatic breast cancer (mBC). 
• Review presented Phase III data with HER2-directed ADC therapy as a compo­nent of first-line and maintenance therapy, and consider the current role of this strategy for HER2-positive mBC. 
• Recognize available research findings with HER2-targeted tyrosine kinase inhibitors as a component of maintenance therapy, and reflect on the potential utility of this approach for patients with HER2-positive mBC.  
• Design an optimal approach to the care of patients with HER2-positive breast cancer and central nervous system metastases, evaluating the implications of prior treatment exposure, symptomatology, extent of and time to new onset of disease and other factors. 
• Implement a plan of care to recognize and manage toxicities associated with agents and regimens commonly employed in the care of patients with HER2-positive breast cancer. 
• Consider ongoing clinical research studies evaluating novel agents and treatment strategies under development for HER2-positive breast cancer, and counsel patients regarding the potential benefits of trial participation. 

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

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

Prof Harbeck — Consulting Agreements: Bayer HealthCare Pharmaceuticals, Exact Sciences Corporation, Pfizer Inc; Contracted Research (All to Institution): AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Lilly, Menarini Group, MSD, Roche Laboratories Inc, Stemline Therapeutics Inc; Data and Safety Monitoring Boards/Committees: Gilead Sciences Inc, IQVIA; Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Gilead Sciences Inc, Lilly, Medscape, Menarini Group, MSD, Novartis, Pfizer Inc, Pierre Fabre, Roche Laboratories Inc, Stemline Therapeutics Inc, Viatris, Zuellig Pharma; Nonrelevant Financial Relationships: High5MD, Springer, WSG (Women’s Cancer Study Group) — minority ownership. Dr Krop — Advisory Committees: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Merck KGaA, Puma Biotechnology Inc, Stemline Therapeutics Inc, Zentalis Pharmaceuticals; Consulting Agreements: AstraZeneca Pharmaceuticals LP. Additional faculty to be announced.

MODERATOR
Dr Tolaney — Advisory Committees: Valanx Biotech Gmbh; Consulting Agreements: Aktis Oncology, Ambrx Inc, Artios Pharma Limited, Arvinas, AstraZeneca Pharmaceuticals LP , Avenzo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Bicycle Therapeutics, BioNTech SE, Boehringer Ingelheim Pharmaceuticals Inc, Boundless Bio, Bristol Myers Squibb, Celcuity, Circle Pharma, Corcept Therapeutics Inc, Cullinan Therapeutics, Daiichi Sankyo Inc, Denali Therapeutics,Ellipses Pharma, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Launch Therapeutics, Lilly, Menarini Group, Merck, Mersana Therapeutics Inc, Novartis, Olema Oncology, Ottimo Pharma, Pfizer Inc, Relay Therapeutics, Reveal Genomics, Samsung Bioepis, Seagen Inc, Stemline Therapeutics Inc, Summit Therapeutics, SystImmune Inc, Tempus, Veracyte Inc, Zuellig Pharma; Contracted Research (to Institution): AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Menarini Group, Merck, NanoString Technologies, Novartis, Olema Oncology, OncoPep, Pfizer Inc, Seagen Inc, Stemline Therapeutics Inc; Travel Support: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Lilly, Pfizer Inc, Roche Laboratories Inc.

Research To Practice CME Planning Committee Members, Staff and Reviewers
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Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, and Puma Biotechnology Inc.

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