A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
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Health Professionals
What is the purpose of this trial?
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Alice Mookerjee
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Emily Kopas, APRN, OCN
- Eric Winer, MD
- Gineesha Abraham
- Ian Krop, MD, PhD
- 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
- Maryam Lustberg, MD, MPH
- Melissa Gambaccini, APRN, AOCNP, FNPC
- Michael Cohenuram, MD
- Michael DiGiovanna, MD, PhD
- Michelle Corso
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Sara Anastasio, RN
- Sarah Elizabeth Schellhorn, MD
- Tara Sanft, MD
- Vanna Dest
- Vidya Kesavan
- Virginia Syombathy
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated05/07/2025
- Study HIC#2000039199