An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
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Health Professionals
What is the purpose of this trial?
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
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Principal Investigator
Sub-Investigators
- Adriana Matutino Kahn, MD
- Agatha Hecht
- Alessia Donadio, MD
- Alice Mookerjee
- Alison Johnson
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Beverly Drucker, MD, PhD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jeremy Kortmansky, MD
- Jing Du, MD, PhD
- Jose Morales-Marin
- Justin Persico, MD
- Karishma Mehra, MBBS
- Kathleen Fenn, MD
- Kathryn Mason
- Kayla Martello
- Kristen Hoxie
- Lajos Pusztai, MD, DPhil
- Larisa Fleysher
- Laura Sabourin
- Madeline Santiago
- Mariya Rozenblit, MD
- Melissa Gambaccini
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Renee Moye
- Sara Anastasio, RN
- Sarah Elizabeth Schellhorn, MD
- Tara Sanft, MD
- Vanna Dest
- Vidya Kesavan
- Virginia Syombathy
- Zia Rahman, MD
- Last Updated11/21/2024
- Study HIC#2000037395