A Phase 3 Study of MK-2870 Plus Pembrolizumab Versus Pembrolizumab Alone or With Chemotherapy in People Who Had Surgery for Triple-Negative Breast Cancer

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Full Title

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

Purpose

Researchers are comparing different treatments for triple-negative breast cancer (TNBC). The people in this study have TNBC that has been surgically removed.

If you join this study, you will be randomly assigned to get one of these treatments:

  • MK-2870 (sacituzumab tirumotecan) plus pembrolizumab immunotherapy
  • Pembrolizumab alone or with capecitabine chemotherapy

MK-2870, pembrolizumab, and standard chemotherapy work against cancer cells in different ways. Researchers think MK-2870 and pembrolizumab may work better than pembrolizumab and chemotherapy or pembrolizumab alone. Capecitabine is taken orally (by mouth) and the other drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have TNBC that was first treated with pembrolizumab and chemotherapy and then surgically removed within 12 weeks of the study.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Nour Abuhadra’s office at 646-888-4451.

Protocol

25-057

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06393374