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NCT06312176 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Breast Neoplasms, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,200
Enrollment target
20
Study locations

NCT06312176: Recruiting Phase 3 study of Breast Neoplasms, sponsored by Merck Sharp & Dohme.

NCT06312176 is a Phase 3 study of Breast Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,200 participants, above the 557-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06312176, a Phase 3 study of Breast Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,200 participants
Enrollment target
20
Study locations

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.

Primary Outcome

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). 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 considered PD. PFS as assessed by blinded independ

Conditions Studied

Breast Neoplasms

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

FieldValue
Enrollment Target 1,200 participants
Start Date 2024-04-14
Est. Completion 2031-04-12
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06312176 shows while recruiting

NCT06312176 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 557-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (115% higher).

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.

NCT06312176 names 20 study sites across 10 states, led by California, Colorado, Florida.

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.

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).

Who is sponsoring clinical trial NCT06312176?

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

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.

Learn More About Clinical Trials

Similar trials for 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 NCT06312176's enrollment target sits among peer trials

1,200 9th of 97 higher than 89 of 97 other Breast Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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 NCT06312176

Source: ClinicalTrials.gov NCT06312176, the US trial registry maintained by the National Library of Medicine. NCT06312176 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.