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NCT06393374 · ClinicalTrials.gov registry record · Phase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
A Phase 3 study of Triple Negative Breast Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,530
- Enrollment target
- 20
- Study locations
NCT06393374 is a Phase 3 study of Triple Negative Breast Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,530 participants, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (554% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT06393374, a Phase 3 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,530 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,530 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2037-12-14 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,530 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (554% 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 Cancer appearing as the primary indexed condition, and to 3 interventions - of which Sacituzumab tirumotecan is the first listed.
NCT06393374 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Alabama.
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.
What interventions are being tested in trial NCT06393374?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT06393374?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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