To begin each module one of the faculty will present an instructive case from his or her practice to frame a handful of educational issues and allow the panel to describe how they currently think through these situations. Members of the audience will be invited to use the iPads provided to participate in interactive polling related to the cases and issues being discussed. Another faculty member will then deliver a presentation during which he or she will review relevant data sets and ongoing trials related to the clinical scenarios under review, which will be followed by moderated panel discussion.

MODULE 1: Available and Emerging Data Sets Shaping the Management of Localized HER2-Positive Breast Cancer (BC) — Dr Rugo

• Design, eligibility criteria and patient accrual for the Phase III KATHERINE study of adjuvant T-DM1 versus trastuzumab for patients with HER2-positive primary BC and residual disease after preoperative therapy
• Key efficacy and safety results from the KATHERINE trial; clinical and research implications of the recent FDA approval of this approach
• Safety profile of T-DM1 versus trastuzumab documented in the KATHERINE trial
• FDA approval and patient selection for pertuzumab as part of adjuvant treatment; indications for adjuvant pertuzumab for patients receiving it as part of neoadjuvant therapy
• Optimal integration of postadjuvant neratinib into clinical algorithms; patient selection and clinical factors guiding its use in practice

MODULE 2: Use of Genomic Classifiers in Clinical Decision-Making for Patients with ER-Positive Early BC — Dr Kaklamani

• Design, eligibility criteria, primary and secondary endpoints and major clinical findings from the Phase III TAILORx intermediate-risk cohort
• Implications of the TAILORx intermediate-risk cohort results for adjuvant treatment for pre- and postmenopausal patients with early BC
• Utility of other genomic classifiers beyond the 21-gene Recurrence Score^® assay in ER-positive early BC
• Updates to NCCN guidelines on the prioritization and role of genomic assays in node-negative and node-positive, ER-positive early BC
• Use of genomic assays in clinical decision-making for patients completing 5 years of adjuvant endocrine therapy

MODULE 3: Selection and Sequence of Therapy for ER-Positive, HER2-Negative Metastatic BC (mBC); Novel Agents and Strategies Under Evaluation in ER-Positive Disease — Prof André

• Research data with and current clinical role of CDK4/6 inhibitors for premenopausal, postmenopausal and elderly patients with ER-positive mBC
• Incidence and severity of toxicities with palbociclib, ribociclib or abemaciclib in pivotal trials
• Active clinical trials evaluating novel CDK4/6 inhibitor combinations in earlier disease settings
• Incidence of mutations in phosphatidylinositol-3 kinase (eg, PIK3CA) in patients with hormone receptor-positive mBC
• Design, eligibility and key efficacy and safety findings of the Phase III SOLAR-1 trial evaluating alpelisib/fulvestrant for men and postmenopausal women with ER-positive, HER2-negative mBC with PIK3CA mutations; potential clinical role and optimal side-effect management

MODULE 4: Immunotherapy as a Rational Therapeutic Strategy in BC — Dr Tolaney

• Early research experience with anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy for HER2-negative mBC
• Design, eligibility criteria and patient accrual for the Phase III IMpassion130 trial evaluating atezolizumab with nab paclitaxel as first-line therapy for triple-negative mBC
• Immune-related and other adverse events with combination therapy on the IMpassion130 study
• FDA approval of atezolizumab/nab paclitaxel for patients with PD-L1-positive unresectable locally advanced or metastatic triple-negative BC; integration of this approach into clinical practice
• Ongoing Phase III evaluation of anti-PD-1/PD-L1 antibodies alone or with other systemic therapies for localized, locally advanced and metastatic BC

MODULE 5: Protocol and Off-Protocol Decision-Making for Patients with HER2-Positive mBC — Dr Pegram

• Published and ongoing investigations of neratinib/capecitabine for patients with HER2-positive mBC, including those with CNS metastases
• Mechanism of action of tucatinib, a small molecule inhibitor selective for HER2: Associated CNS permeability and related activity in patients with HER2-positive brain metastases
• Activity and safety of tucatinib with trastuzumab/capecitabine in patients with HER2-positive mBC; ongoing pivotal Phase II HER2CLIMB trial of trastuzumab/capecitabine with or without tucatinib
• Structural makeup of and early efficacy and safety with the antibody-drug conjugate trastuzumab deruxtecan for HER2-positive mBC; FDA breakthrough therapy designation and emerging data from the Phase II DESTINY-Breast01 trial
• Emerging results from the Phase III SOPHIA trial comparing margetuximab/chemotherapy to trastuzumab/chemotherapy for HER2-positive mBC

MODULE 6: Role of PARP Inhibitors, Novel Agents in mBC; Male Breast Cancer — Dr Traina

• Phase III data sets supporting the FDA approvals for olaparib (OlympiAD) and talazoparib (EMBRACA) for patients with mBC and a BRCA germline mutation
• Available data with and ongoing evaluation of other PARP inhibitors (eg, veliparib, niraparib) in BC
• Novel agents and strategies under development for triple-negative BC
• Male breast cancer: A disease distinct from female breast cancer