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

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

Module 1: Evolving Approach to First-Line Therapy for Metastatic Triple-Negative Breast Cancer (mTNBC)

• Outcomes with historical standard treatments for PD-L1-negative and PD-L1-positive mTNBC; rationale for moving TROP2-directed antibody-drug conjugates (ADCs) earlier in the treatment sequence
• Structural and mechanistic similarities and differences among the approved and investigational TROP2-directed ADCs, sacituzumab govitecan, datopotamab deruxtecan (Dato-DXd) and sacituzumab tirumotecan (sac-TMT); implications for efficacy and tolerability
• Major efficacy and safety findings from the Phase III ASCENT-03 and TROPION-Breast02 trials comparing single-agent sacituzumab govitecan and Dato-DXd, respectively, to chemotherapy as first-line treatment for patients with mTNBC not eligible for immunotherapy; FDA approvals of both regimens and clinical implications
• Published outcomes from the Phase III ASCENT-04/KEYNOTE-D19 study evaluating sacituzumab govitecan in combination with pembrolizumab for patients with previously untreated PD-L1-positive mTNBC
• FDA approval of sacituzumab govitecan both as a monotherapy and in combination with pembrolizumab for the first-line treatment of mTNBC; optimal incorporation into clinical practice
• Updated NCCN Guidelines supporting the use of sacituzumab govitecan, as monotherapy and combined with pembrolizumab, and Dato-DXd monotherapy as first-line therapy for mTNBC; current and future roles of these strategies
• Ongoing Phase III TROPION-Breast05 and TroFuse-011 studies evaluating Dato-DXd and sac-TMT, respectively, in combination with anti-PD-1/PD-L1 antibodies as first-line therapy for mTNBC; estimated completion dates and clinical implications
• Long-term data guiding the use of PARP inhibitors for patients with mTNBC and BRCA or other homologous recombination repair gene mutations; current application in the front-line setting

Module 2: Selection and Sequencing of Therapy for Relapsed/Refractory (R/R) mTNBC; Novel Agents and Strategies Under Investigation

• Extended follow-up with and current role of sacituzumab govitecan for R/R mTNBC
• Updated data with trastuzumab deruxtecan (T-DXd) in the subgroup of patients with previously treated hormone receptor-negative, HER2-low advanced breast cancer in the Phase III DESTINY-Breast04 study; current role as one of the available treatment options
• Known mechanisms of resistance to available ADCs; current role of T-DXd after disease progression on sacituzumab govitecan or Dato-DXd and vice versa
• Mechanism of antitumor activity and structural components of the EGFR x HER3 ADC izalontamab brengitecan (iza-bren)
• Available efficacy and safety data with iza-bren for mTNBC, including from the Chinese Phase III PANKU-Breast02 study; ongoing investigation in the up-front setting in a global population in the Phase III IZABRIGHT-Breast01 trial
• Mechanism of action of the PD-L1 x VEGF-A bispecific antibody pumitamig and rationale for its evaluation as treatment for advanced TNBC
• Early efficacy and safety outcomes with pumitamig/chemotherapy as first- and second-line therapy for patients with mTNBC; ongoing Phase III ROSETTA Breast-01 trial for previously untreated PD-L1-negative disease
• Other promising novel agents and strategies under investigation for patients with mTNBC

Module 3: Current and Future Management of Localized TNBC

• Long-term data from the Phase III KEYNOTE-522 trial evaluating neoadjuvant pembrolizumab combined with chemotherapy and continued as a single agent after surgery for high-risk localized TNBC
• Patient selection for and practical application of neoadjuvant and adjuvant pembrolizumab
• Key efficacy and safety findings, including overall survival outcomes, among patients with TNBC from the Phase III OlympiA trial assessing adjuvant olaparib versus placebo for BRCA-mutant, high-risk, HER2-negative breast cancer
• Current role of adjuvant olaparib for patients with TNBC and a germline BRCA1/2 mutation
• Ongoing Phase III trials evaluating TROP2-targeted ADCs as a component of neoadjuvant or adjuvant therapy for localized TNBC: TROPION-Breast04, ASCENT-05, ADAPT-TN-III, ADAPT-TN-IV, TroFuse-012 and TroFuse-032; estimated completion dates

Module 4: Tolerability Considerations with ADCs for TNBC

• Spectrum, incidence and severity of common and unique adverse events (AEs) with different ADCs used in the management of TNBC
• Monitoring and management of acute “chemotherapy-like” AEs, such as cytopenias and gastrointestinal events, reported with ADCs
• Recommended algorithms for mitigating more serious (eg, interstitial lung disease, left ventricular dysfunction) or unique (eg, oral mucositis/stomatitis, ocular AEs) toxicities documented with one or more ADCs
• Effect on the tolerability profile of TROP2-targeted ADCs when they are combined with anti-PD-1/PD-L1 antibodies; strategies to determine the etiology of AEs that could be attributable to either agent
• Implications of the tolerability profiles for selecting ADCs for patients with mTNBC

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

• Consider available research data evaluating anti-PD-1/PD-L1 antibody-based approaches for patients with localized triple-negative breast cancer (TNBC), and assess the role of these strategies in clinical practice.
• Evaluate published research findings, patient preferences and clinical factors, such as PD-L1, HER2 and BRCA status, in the selection and sequencing of available therapeutic agents and strategies for patients with newly diagnosed metastatic TNBC (mTNBC).
• Review published research data supporting antibody-drug conjugate (ADC) therapy in combination with anti-PD-1/PD-L1 antibodies for patients with mTNBC, and use this information to make appropriate treatment recommendations.
• Assess recently presented clinical research findings with TROP2-directed ADC monotherapy as first-line treatment for mTNBC, and optimally incorporate these agents into patient care.
• Understand the biological rationale for the evaluation of HER2-directed ADCs for HER2-low mTNBC, and identify patients appropriate for this treatment approach.
• Recognize the spectrum, frequency and severity of treatment-emergent adverse events associated with agents and approaches commonly used in the management of TNBC, and develop strategies to monitor for, prevent and manage these complications.
• Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for TNBC.

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.

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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 disclosures to be announced.

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

Prof Curigliano — Advisory Committees, Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Exact Sciences Corporation, Gilead Sciences Inc, Lilly, Menarini Group, Novartis, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: Lilly, Pfizer Inc, Roche Laboratories Inc. Prof Schmid — Consulting Agreements: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Celgene Corporation, Eisai Inc, Merck, Novartis, Pfizer Inc, Puma Biotechnology Inc, Roche Laboratories Inc. Dr Traina — Advisory Committees and Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, BioNTech SE, Bristol Myers Squibb, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Ellipses Pharma, Exact Sciences Corporation, Genentech, a member of the Roche Group, Gilead Sciences Inc, Merck, Pfizer Inc, Stemline Therapeutics Inc, Veracyte Inc; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, BioNTech SE, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Pfizer Inc.

MODERATOR
Dr Mahtani — Consulting Agreements: Agendia Inc, Celcuity, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Hologic Inc, Lilly, Novartis, Pfizer Inc, Puma Biotechnology Inc, Stemline Therapeutics Inc; Contracted Research: Gilead Sciences Inc.

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 AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, and Daiichi Sankyo Inc.

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.

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