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RECRUITING Phase 3

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

NCT06393374 · View on ClinicalTrials.gov ↗

Study Summary

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Interventions

  • BIOLOGICAL Sacituzumab tirumotecan
  • BIOLOGICAL Pembrolizumab
  • DRUG Capecitabine

Study Locations (20)

California

  • MemorialCare Orange Coast Medical Center ( Site 9501) — Fountain Valley
  • Scripps Cancer Center ( Site 0052) — La Jolla
  • Cancer and Blood Specialty Clinic ( Site 0008) — Los Alamitos
  • Kaiser Permanente - Oakland ( Site 0079) — Oakland
  • Profound Research LLC ( Site 0105) — Oceanside
  • Kaiser Permanente - Roseville ( Site 0081) — Roseville
  • Kaiser Permanente - San Francisco ( Site 0080) — San Francisco
  • Kaiser Permanente - Santa Clara ( Site 0082) — Santa Clara
  • Providence Medical Foundation ( Site 9543) — Santa Rosa
  • Kaiser Permanente Vallejo Medical Center ( Site 0060) — Vallejo
  • Kaiser Permanente - Walnut Creek ( Site 0078) — Walnut Creek
  • Bass Medical Group ( Site 0089) — Walnut Creek

Florida

  • Comprehensive Hematology Oncology ( Site 0091) — St. Petersburg
  • Cleveland Clinic Martin North Hospital ( Site 0114) — Stuart

Alabama

  • Infirmary Cancer Care ( Site 0001) — Mobile

Arizona

  • Ironwood Cancer & Research Centers-Research ( Site 0054) — Chandler

Colorado

  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046) — Grand Junction

Connecticut

  • Yale Cancer Center ( Site 0053) — New Haven

Georgia

  • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040) — Thomasville

Illinois

  • Illinois Cancer Specialists (ICS) ( Site 8010) — Arlington Heights

Trial Details

FieldValue
Enrollment Target 1,530 participants
Start Date 2024-06-24
Est. Completion 2037-12-14
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06393374

The ClinicalTrials.gov registry entry for NCT06393374 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 1,530 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 Cancer appearing as the primary indexed condition, and to 3 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: NCT06393374 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT06393374 about?

NCT06393374 is a clinical study titled "Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)". This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and di...

What is the current status of trial NCT06393374?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,530 participants. The study started on 2024-06-24. Estimated completion is 2037-12-14.

What conditions does trial NCT06393374 study?

This clinical trial studies the following conditions: Triple-Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06393374?

The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06393374?

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 NCT06393374 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial