Clinical Trial

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

Study acronym: BREnnA
Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
Protocol Amendment History 7 changes
notable Trial sites expanded: 109 -> 152 locations 2026-08-06
notable Trial sites expanded: 55 -> 109 locations 2026-07-10
notable Trial sites expanded: 4 -> 55 locations 2026-06-11
critical Recruitment opened 2026-05-12
notable Trial sites expanded: 0 -> 4 locations 2026-05-12
notable Primary completion pushed: 2029-03-30 -> 2029-05-01 2026-05-12
minor Completion pushed: 2032-08-28 -> 2032-09-29 2026-05-12
Trial Details
NCT Number NCT07413939
Lead Sponsor Hoffmann-La Roche
Conditions HER2-positive Breast Cancer
Enrollment 650 participants
Start Date 2026-05-21
Primary Completion 2029-05-01 (estimated)
Study Completion 2032-09-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-05