deltatrials
Recruiting PHASE3 INTERVENTIONAL 3-arm 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)

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)

Sponsor: Merck Sharp & Dohme LLC

Updated 12 times since 2025 Last updated: Mar 12, 2026 Started: Mar 16, 2025 Primary completion: May 18, 2030 Completion: May 18, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Triple Negative Breast Neoplasms, this trial is actively recruiting participants. The trial is conducted by Merck Sharp & Dohme LLC and has accumulated 12 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2025 – ~May 2025 · 2 months · monthly snapshotNot Yet Recruiting~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 5 months · monthly snapshotRecruiting

Change History

12 versions recorded
  1. Mar 2026 — Present [monthly]

    Recruiting PHASE3

  2. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE3

  3. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE3

  4. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  5. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

Show 7 earlier versions
  1. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

  4. Jul 2025 — Aug 2025 [monthly]

    Recruiting PHASE3

  5. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE3

  6. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  7. Mar 2025 — May 2025 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

For direct contact, visit the study record on ClinicalTrials.gov .