RO7771950
Sponsors
F. Hoffmann-La Roche AG, Hoffmann-La Roche, F. Hoffmann La Roche Ltd
Conditions
CancerHER2-positive Breast CancerPretreated Unresectable Locally Advanced or Metastatic human epidermal growth factor receptor 2 (HER2)-Positive Breast Cancerwith or without Central Nervous System (CNS) Metastases
Phase 2
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
RecruitingNCT07413939
Start: 2026-05-21End: 2032-09-29Target: 650Updated: 2026-09-03
A two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases
Not yet recruitingCTIS2025-524498-17-00
Target: 107Updated: 2026-04-29
A TWO-PART, SEAMLESS, MULTICENTER, RANDOMIZED, OPEN-LABEL, ADAPTIVE PHASE II/III STUDY OF THE BLOOD-BRAIN BARRIER PENETRANT RO7771950 VERSUS TUCATINIB, BOTH IN COMBINATION WITH TRASTUZUMAB AND CAPECITABINE, IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER, WITH OR WITHOUT CENTRAL NERVOUS SYSTEM METASTASE
Active, not recruitingPACTR202605565481660
Start: 2026-04-01Target: 4Updated: 2026-09-14