Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Triple Negative Breast Cancer, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
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 |
What NCT06393374 shows while recruiting
NCT06393374 is an interventional study that assigns participants to a tested intervention. Its 1,530 participants enrollment target places it among the larger protocols in the corpus, above the 234-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (554% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
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 NCT06393374's enrollment target sits among peer trials
1,530 4th of 118 higher than 115 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer 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
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
ACTIVE NOT RECRUITING · Phase 3
-
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
ACTIVE NOT RECRUITING · Phase 3
-
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07114510 · 1,530 participants · NA
Optimal Ventilation for Cardiac Arrest
- NCT06623097 · 1,528 participants · NA
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
- NCT06257082 · 1,526 participants · NA
Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
- NCT06842875 · 1,536 participants · NA
Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI