OncoMatch/Clinical Trials/NCT06312176
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Is NCT06312176 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.
Treatment: Sacituzumab tirumotecan · Pembrolizumab · Paclitaxel · Nab-paclitaxel · Capecitabine · Liposomal doxorubicin — The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Required: PR (PGR) positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — unresectable locally advanced/metastatic
radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
Must have received: CDK4/6 inhibitor — in combination with endocrine therapy
with one in combination with a CDK4/6 inhibitor
Cannot have received: chemotherapy
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Lab requirements
Blood counts
Kidney function
Liver function
Has adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ironwood Cancer & Research Centers ( Site 0066) · Chandler, Arizona
- Banner MD Anderson Cancer Center-Oncology ( Site 0004) · Gilbert, Arizona
- Providence Medical Foundation-Oncology ( Site 0020) · Fullerton, California
- Moores Cancer Center ( Site 0059) · La Jolla, California
- Cancer and Blood Specialty Clinic ( Site 0001) · Los Alamitos, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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