All events moderated by:
Neil Love, MD
Research To Practice
Miami, Florida

Monday, January 25, 2021 from 5:00 PM – 6:00 PM Eastern Time

Monday, March 8, 2021 from 5:00 PM – 6:00 PM Eastern Time

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Puma Biotechnology Inc and Seagen Inc.

Topics to Be Discussed

MODULE 1: Considerations in the Care of Patients with Localized HER2-Positive Breast Cancer (BC) Receiving Neoadjuvant Systemic Therapy

• Indications for neoadjuvant systemic therapy in patients with HER2-positive localized BC; clinical factors (eg, tumor size, nodal status, patient age, planned surgical approach) affecting the decision to administer neoadjuvant treatment
• Long-term efficacy outcomes with the use of anthracycline- and nonanthracycline-based neoadjuvant systemic therapy platforms; prognosis for patients who experience a pathologic complete response compared to those who do not
• Key efficacy and safety results from the Phase III KATHERINE trial; clinical and research implications of the FDA approval of adjuvant T-DM1 for patients with HER2-positive primary BC and residual disease after preoperative therapy
• Indications for the use of adjuvant pertuzumab for patients receiving it as part of neoadjuvant therapy
• Design of and rationale for other planned clinical trials seeking to use pathologic response assessment to optimize therapy for localized HER2-positive BC

MODULE 2: Adjuvant and Extended-Adjuvant Therapy for Patients with Localized HER2-Positive BC

• Selection of postoperative systemic therapy for patients with HER2-positive localized BC who have not received prior neoadjuvant systemic therapy
• Available efficacy and safety results from and clinical implications of the randomized Phase II ATEMPT trial comparing adjuvant T-DM1 to paclitaxel/trastuzumab for Stage I HER2-positive BC
• Long-term results of the Phase III APHINITY trial evaluating the addition of pertuzumab to chemotherapy and trastuzumab as adjuvant treatment for HER2-positive localized BC; patient selection for pertuzumab as a component of adjuvant chemobiologic therapy
• Current role of neratinib as extended-adjuvant therapy; patient selection and clinical factors (eg, ER/PR status, tumor size, nodal status) guiding its use in practice
• Ongoing and planned clinical trials attempting to improve upon outcomes with existing adjuvant therapy techniques in patients with localized HER2-positive BC

MODULE 3: Optimizing the Management of HER2-Positive Metastatic BC (mBC)

• Clinical factors affecting the selection of first- and later-line therapy for patients with HER2-positive mBC (eg, prior HER2-directed therapy, symptomatology, performance status, disease-free interval, sites of metastases)
• Available efficacy and safety findings from the Phase III NALA study of neratinib/capecitabine or lapatinib/capecitabine for patients with HER2-positive mBC; current role of neratinib in mBC
• Efficacy and safety data from the Phase II DESTINY-Breast01 trial leading to the FDA approval of trastuzumab deruxtecan for HER2-positive mBC; optimal integration into current practice
• Biologic rationale for and ongoing evaluation of trastuzumab deruxtecan for patients with HER2-low advanced BC
• Activity and safety of tucatinib with trastuzumab/capecitabine in patients with HER2-positive mBC in the pivotal Phase II HER2CLIMB trial; recent FDA approval and current clinical role
• Other novel strategies under investigation for HER2-positive mBC

MODULE 4: Treatment of HER2-Positive Brain Metastases

• Incidence of CNS metastases in patients with HER2-positive mBC; local management strategies for those diagnosed with brain metastases, including stereotactic radiosurgery
• Comparative levels of CNS penetration with approved and investigational agents for HER2-positive mBC
• Available data with and optimal sequencing of neratinib/capecitabine for HER2-positive brain metastases
• Proportion of patients with brain metastases in the HER2CLIMB study of tucatinib/trastuzumab/capecitabine; antitumor activity observed with tucatinib in this population
• Efficacy of trastuzumab deruxtecan in patients with CNS metastases in the DESTINY-Breast01 trial
• Appropriate management of progressive HER2-positive disease that is limited to the CNS

MODULE 5: Incidence and Management of Adverse Events Associated with HER2-Targeted Therapy

• Frequency and severity of side effects (thrombocytopenia, neuropathy, fatigue, nausea) associated with adjuvant T-DM1 in the KATHERINE and ATEMPT studies; rates of dose reductions, delays and discontinuation
• Prevention and management of gastrointestinal (GI) and other toxicities associated with neratinib; utility of prophylactic measures in preventing or ameliorating neratinib-associated diarrhea and vomiting
• Incidence of interstitial lung disease observed with trastuzumab deruxtecan in the DESTINY-Breast01 study; recommendations for monitoring, prevention and management
• Spectrum, incidence, severity and management of other toxicities reported with trastuzumab deruxtecan
• Incidence, severity and management of GI and other clinically relevant toxicities with tucatinib

Target Audience
These activities are intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

Learning Objectives
At the conclusion of the activity, participants should be able to

• Appreciate the key clinical variables that affect the use of preoperative therapy and the selection of therapeutic regimens for patients with HER2-overexpressing localized breast cancer (BC), and integrate this information into treatment decision-making.
• Apply available research evidence to individualize the selection and use of adjuvant systemic therapy for patients with HER2-positive localized BC who received neoadjuvant treatment.
• Evaluate published research data to guide the selection and duration of adjuvant and/or extended-adjuvant therapy for patients with HER2-overexpressing localized BC.
• Implement a long-term clinical plan for the management of advanced HER2-positive BC, incorporating existing and recently approved targeted agents and regimens.
• Design an optimal approach to the clinical care of patients with HER2-positive BC and CNS metastases, considering the implications of prior therapeutic exposure, symptomatology and other factors.
• Recognize common and rare side effects associated with approved and investigational anti-HER2 agents, and use this information to develop supportive management plans for patients undergoing treatment for HER2-positive BC.
• Assess ongoing clinical research studies evaluating novel agents and treatment strategies under development for HER2-positive BC, and counsel patients regarding the potential benefits of trial participation.

CME Credit Form
A CME credit form will be emailed to participants within 3 business days of the activity.

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

Credit Designation Statement
Research To Practice designates each live activity 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.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the 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 (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Dr Hamilton — Advisory Committee: Boehringer Ingelheim Pharmaceuticals Inc, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Lilly, Mersana Therapeutics, Pfizer Inc, Puma Biotechnology Inc, Seagen Inc; Consulting Agreement: Flatiron Health; Contracted Research: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, ArQule Inc, AstraZeneca Pharmaceuticals LP, BerGenBio ASA, Boehringer Ingelheim Pharmaceuticals Inc, Clovis Oncology, Curis Inc, CytomX Therapeutics, Daiichi Sankyo Inc, eFFECTOR Therapeutics Inc, Eisai Inc, EMD Serono Inc, FUJIFILM Pharmaceuticals USA Inc, Genentech, a member of the Roche Group, H3 Biomedicine, Hutchison MediPharma, Immunomedics Inc, InventisBio, Kadmon Corporation, Leap Therapeutics Inc, Lilly, Lycera, MacroGenics Inc, Mallinckrodt Pharmaceuticals, Marker Therapeutics Inc, Medivation Inc, a Pfizer Company, Mersana Therapeutics, Merus BV, Novartis, NuCana, OncoMed Pharmaceuticals Inc, Pfizer Inc, PharmaMar, Radius Health Inc, Regeneron Pharmaceuticals Inc, Rgenix, Seagen Inc, Stemcentrx, Syndax Pharmaceuticals Inc, Syros Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, TetraLogic Pharmaceuticals, Verastem Inc, Zymeworks; Travel/Accommodations/Expenses (payment or reimbursement of actual expenses): Amgen Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Clovis Oncology, Eisai Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genzyme Corporation, Guardant Health, Helsinn Healthcare SA, Heron Therapeutics, Lexicon Pharmaceuticals Inc, Lilly, Medivation Inc, a Pfizer Company, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Sysmex Corporation, Tesaro, A GSK Company. Dr Pegram — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, MacroGenics Inc, Merck, Novartis, Odonate Therapeutics, Pfizer Inc, Puma Biotechnology Inc, Samsung Bioepis, Seagen Inc, Zymeworks; Contracted Research: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Pfizer Inc, Zymeworks; Data and Safety Monitoring Board/Committee: Roche Laboratories Inc; Employment (Spouse): Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company.

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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies Corporation, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Guardant Health, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seagen Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc and Verastem Inc.

Research To Practice CME Planning Committee Members, Staff and Reviewers — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Puma Biotechnology Inc and Seagen Inc.