OncRef

Clinical Trial: NCT06841354

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-10-13

Study Overview

Brief Summary

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Official Title

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Conditions

Triple Negative Breast Neoplasms

Intervention / Treatment

  • Biological: Sacituzumab tirumotecan
  • Biological: Pembrolizumab
  • Drug: Rescue Medication
  • Drug: Paclitaxel
  • Drug: Nab-paclitaxel
  • Drug: Gemcitabine
  • Drug: Carboplatin

Other Study ID Numbers

  • 2870-011
  • MK-2870-011
  • TroFuse-011
  • 2024-516834-36-00
  • U1111-1311-2310

Start Date (Actual)

2025-03-16

Primary Completion Date (Estimated)

2030-05-18

Study Completion Date (Estimated)

2030-05-18

Enrollment (Estimated)

1000

Study Type

Interventional

Phase

Phase 3