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Brief 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)
Official Title: 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
Study ID: NCT06312176
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hematology Oncology Associates of Rockland ( Site 0054), Nyack, New York, United States
Queen Mary Hospital ( Site 2040), Hksar, , Hong Kong
Rambam Health Care Campus-Oncology Division ( Site 1452), Haifa, , Israel
Hadassah Medical Center ( Site 1451), Jerusalem, , Israel
Rabin Medical Center ( Site 1453), Petah Tikva, , Israel
Sheba Medical Center ( Site 1450), Ramat Gan, , Israel
Asan Medical Center-Department of Oncology ( Site 2352), Seoul, , Korea, Republic of
Brust-Zentrum ( Site 1841), Zürich, Zurich, Switzerland
National Cheng Kung University Hospital-Surgery ( Site 2411), Tainan, , Taiwan
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR