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A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-paclitaxel
- DRUG Sacituzumab tirumotecan
Study Locations (20)
California
- Providence Medical Foundation-Oncology ( Site 0020) — Fullerton
- Moores Cancer Center ( Site 0059) — La Jolla
- Cancer and Blood Specialty Clinic ( Site 0001) — Los Alamitos
Colorado
- University of Colorado Anschutz Medical Campus ( Site 0061) — Aurora
- UCHealth Cherry Creek Medical Center ( Site 0094) — Denver
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095) — Highlands Ranch
Florida
- AdventHealth Altamonte Springs ( Site 0021) — Altamonte Springs
- University of Florida College of Medicine ( Site 0063) — Gainesville
- Orlando Health Cancer Institute ( Site 0011) — Orlando
Arizona
- Ironwood Cancer & Research Centers ( Site 0066) — Chandler
- Banner MD Anderson Cancer Center-Oncology ( Site 0004) — Gilbert
Connecticut
- Yale Cancer Center ( Site 0060) — New Haven
- Stamford Hospital ( Site 0049) — Stamford
Illinois
- Rush University Medical Center ( Site 0079) — Chicago
- University of Chicago Medical Center ( Site 0067) — Chicago
Maryland
- Greenebaum Comprehensive Cancer Center ( Site 0036) — Baltimore
- Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028) — Baltimore
Georgia
- Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032) — Thomasville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2024-04-14 |
| Est. Completion | 2031-04-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06312176
The ClinicalTrials.gov registry entry for NCT06312176 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 1,200 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 Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab 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: NCT06312176 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, 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 NCT06312176 about?
NCT06312176 is a clinical study titled "A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)". The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally adv...
What is the current status of trial NCT06312176?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2024-04-14. Estimated completion is 2031-04-12.
What conditions does trial NCT06312176 study?
This clinical trial studies the following conditions: 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 NCT06312176?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Sacituzumab tirumotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06312176?
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 NCT06312176 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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