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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 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.

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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.

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

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06841354

The ClinicalTrials.gov registry entry for NCT06841354 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 563-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (78% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.