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NCT06841354 · ClinicalTrials.gov registry record · Phase 3

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 study of Triple Negative Breast Neoplasms, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,000
Enrollment target
20
Study locations

NCT06841354: Recruiting Phase 3 study of Triple Negative Breast Neoplasms, sponsored by Merck Sharp & Dohme.

NCT06841354 is a Phase 3 study of Triple Negative Breast Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,000 participants, above the 563-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06841354, a Phase 3 study of Triple Negative Breast Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also

Conditions Studied

Triple Negative Breast Neoplasms

Interventions

  • BIOLOGICAL Sacituzumab tirumotecan
  • BIOLOGICAL Pembrolizumab
  • DRUG Paclitaxel
  • DRUG Rescue Medication
  • DRUG Nab-paclitaxel

Study Locations (20)

Maryland

  • MedStar Franklin Square Medical Center ( Site 0031) - Baltimore
  • MedStar Good Samaritan Hospital ( Site 0079) - Baltimore
  • MedStar Southern Maryland Hospital Center ( Site 0100) - Clinton
  • MedStar Montgomery Medical Center ( Site 0078) - Olney
  • Holy Cross Hospital ( Site 0091) - Silver Spring

California

  • City of Hope ( Site 0097) - Duarte
  • City of Hope Lennar Foundation Cancer Center ( Site 0099) - Irvine
  • UCLA Department of Medicine - Hematology & Oncology ( Site 0047) - Los Angeles
  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016) - San Francisco

Florida

  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007) - Altamonte Springs
  • Florida Cancer Specialists - East ( Site 7000) - West Palm Beach

Alabama

  • USA Mitchell Cancer Institute ( Site 0090) - Mobile

Arizona

  • Ironwood Cancer & Research Centers ( Site 0036) - Chandler

Connecticut

  • Yale New Haven Hospital ( Site 0001) - New Haven

District of Columbia

  • Washington Hospital Center ( Site 0098) - Washington D.C.

Georgia

  • University Cancer & Blood Center, LLC ( Site 0023) - Athens

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2025-03-16
Est. Completion 2030-05-18
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06841354 shows while recruiting

NCT06841354 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 563-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (78% higher).

The record links to 1 condition, with Triple Negative Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Sacituzumab tirumotecan is the first listed.

NCT06841354 names 20 study sites across 12 states, led by Maryland, California, Florida.

Frequently Asked Questions

What is clinical trial NCT06841354 about?

NCT06841354 is a clinical study titled "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)". 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 o...

What is the current status of trial NCT06841354?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2025-03-16. Estimated completion is 2030-05-18.

What conditions does trial NCT06841354 study?

This clinical trial studies the following conditions: Triple Negative Breast Neoplasms.

What interventions are being tested in trial NCT06841354?

The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Paclitaxel (DRUG), Rescue Medication (DRUG), Nab-paclitaxel (DRUG).

Who is sponsoring clinical trial NCT06841354?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06841354 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Triple Negative Breast Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06841354's enrollment target sits among peer trials

1,000 2nd of 10 the highest of 10 other Triple Negative Breast Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Triple Negative Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06841354

Source: ClinicalTrials.gov NCT06841354, the US trial registry maintained by the National Library of Medicine. NCT06841354 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.