Tests sacituzumab tirumotecan against standard treatment in hormone-positive breast cancer
Tests sacituzumab tirumotecan, alone or with pembrolizumab, in adults with advanced hormone-positive breast cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bunkyo, Fukushima, Gifu, Hidaka, Hiroshima, Isehara, Kagoshima, Kashiwa, Kawasaki, Koto, Kumamoto, Kyoto, Nagoya, Okayama, Osaka, Sagamihara, Sapporo, Sendai, Shinagawa, Shinjuku, Suita, Tsu, and Yokohama, JapanSee the 24 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you been treated with a CDK4/6 inhibitor (for example palbociclib, ribociclib or abemaciclib)?
- Have you had chemotherapy for cancer that has spread or is advanced?
Source: NCT06312176, who can take part
Where in Japan
- Juntendo University Hospital (Site 2468)Bunkyo, JapanNo longer taking part
- Fukushima Medical University Hospital (Site 2461)Fukushima, JapanNo longer taking part
- Gifu University Hospital (Site 2486)Gifu, JapanNo longer taking part
- Saitama Medical University International Medical Center (Site 2462)Hidaka, JapanNo longer taking part
- Hiroshima City Hiroshima Citizens Hospital (Site 2478)Hiroshima, JapanNo longer taking part
- Tokai University Hospital (Site 2473)Isehara, JapanNo longer taking part
- Social medical corporation Hakuaikai Sagara Hospital (Site 2481)Kagoshima, JapanNo longer taking part
- National Cancer Center Hospital East (Site 2463)Kashiwa, JapanNo longer taking part
- St. Marianna University Hospital (Site 2465)Kawasaki, JapanNo longer taking part
- Cancer Institute Hospital of JFCR (Site 2464)Koto, JapanNo longer taking part
- Kumamoto University Hospital (Site 2480)Kumamoto, JapanNo longer taking part
- Kyoto University Hospital (Site 2475)Kyoto, JapanNo longer taking part
- Nagoya City University Hospital (Site 2474)Nagoya, JapanNo longer taking part
- Okayama University Hospital (Site 2485)Okayama, JapanNo longer taking part
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute (Site 2477)Osaka, JapanNo longer taking part
- Kitasato University Hospital (Site 2471)Sagamihara, JapanNo longer taking part
- Hokkaido University Hospital (Site 2460)Sapporo, JapanNo longer taking part
- Tohoku University Hospital (Site 2482)Sendai, JapanNo longer taking part
- Showa Medical University Hospital (Site 2466)Shinagawa, JapanNo longer taking part
- National Center for Global Health and Medicine (Site 2469)Shinjuku, JapanNo longer taking part
- Tokyo Medical University Hospital (Site 2467)Shinjuku, JapanNo longer taking part
- The University of Osaka Hospital (Site 2476)Suita, JapanNo longer taking part
- Mie University Hospital (Site 2483)Tsu, JapanNo longer taking part
- Kanagawa Cancer Center (Site 2472)Yokohama, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06312176EU 2023-504918-29-00
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
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.
Inclusion: Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer; Has 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; Is a chemotherapy candidate; Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization; Has adequate organ function; Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy; Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load; Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion: Has breast cancer amenable to treatment with curative intent; Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment; Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer; Active autoimmune disease that has required systemic treatment in the past 2 years; History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease; Has an active infection requiring systemic therapy; Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications.