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Sacituzumab tirumotecan / Breast Neoplasms / Triple Negative Breast Neoplasms · Phase 3 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 clinical trial registration for sacituzumab tirumotecan combined with pembrolizumab and chemotherapy versus pembrolizumab and chemotherapy alone in early-stage, high-risk breast cancer. No results are currently reported in this registry record; the trial is actively recruiting and designed to assess pathological complete response and event-free survival.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms; age from 18 Years. Intervention: sac-TMT. Compared with: Chemotherapy — Active Comparator. n = 2,400. 319 sites across 39 countries.
This is a Phase 3 clinical trial registration for sacituzumab tirumotecan combined with pembrolizumab and chemotherapy versus pembrolizumab and chemotherapy alone in early-stage, high-risk breast cancer. No results are currently reported in this registry record; the trial is actively recruiting and designed to assess pathological complete response and event-free survival.
Recruitment status is active; final efficacy and safety data are not yet available.
Results from this trial, when available, will inform whether sacituzumab tirumotecan added to standard neoadjuvant chemotherapy and pembrolizumab improves pathological response and long-term survival in these high-risk early breast cancer subtypes. This registration does not yet provide outcome data.
This is a Phase 3 trial registration with no results reported; it describes a planned study of sacituzumab tirumotecan in early breast cancer, currently recruiting.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial, when available, will inform whether sacituzumab tirumotecan added to standard neoadjuvant chemotherapy and pembrolizumab improves pathological response and long-term survival in these high-risk early breast cancer subtypes. This registration does not yet provide outcome data.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06966700). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 2400 participants (ESTIMATED). Conditions: Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms. Interventions: BIOLOGICAL: Sacituzumab tirumotecan; BIOLOGICAL: Pembrolizumab; DRUG: Rescue Medication; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Doxorubicin; DRUG: Epirubicin; DRUG: Cyclophosphamide; DRUG: Capecitabine; DRUG: Olaparib. Primary outcome measures: Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery , Up to approximately 30 weeks; Event-Free Survival (EFS) , Up to approximately 92 months. Brief summary: Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
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