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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)
NCT06841354 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-03-16 |
| Est. Completion | 2030-05-18 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06841354 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Maryland, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06841354?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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