OncoMatch/Clinical Trials/NCT06966700
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Is NCT06966700 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.
Treatment: Sacituzumab tirumotecan · Pembrolizumab · Rescue Medication · Carboplatin · Paclitaxel · Doxorubicin · Epirubicin · Cyclophosphamide · Capecitabine · Olaparib — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression (low+ (1% to 10% cells))
HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells)
Required: HER2 (ERBB2) wild-type
HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Disease stage
Required: Stage CT1C, N1-N2, CT2, N0-N2, CT3, N0-N2, CT4A-D, N0-N2 (other)
Excluded: Stage STAGE IV, CN3
high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; cT4a-d, N0-N2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: TROP2-targeted antibody-drug conjugate
Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC)
Cannot have received: topoisomerase I inhibitor-containing antibody-drug conjugate
Received prior treatment with a topoisomerase I inhibitor-containing ADC
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Franciscan Health ( Site 0077) · Indianapolis, Indiana
- Ochsner Clinic Foundation ( Site 0021) · New Orleans, Louisiana
- Louisiana State University Health Sciences Shreveport ( Site 0053) · Shreveport, Louisiana
- New England Cancer Specialists ( Site 0051) · Westbrook, Maine
- Mercy Medical Center - Baltimore ( Site 0015) · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06966700 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1C, N1-N2 or CT2, N0-N2 or CT3, N0-N2 or CT4A-D, N0-N2 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify