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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
StatusRecruiting
PhasePhase 2/3
Started2026-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 152 → 186 locations
2026-08-03
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 109 → 152 locations
2026-07-08
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 55 → 109 locations
2026-06-08
minor
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations, References v5
Trial sites expanded: 4 → 55 locations
Start dateestimated 2026-06-01→confirmed 2026-05-21
Eligibility criteria+65 characters
[...] C) with confirmed HER2-positive status by central laboratory. Measurable disease only as per by RECIST v1.1/RANO-BM in stage 1. Non-measurable disease allowed in stage 2. Prev [...] ously untreated CNS metastases, or leptomeningeal metastases. At least one prior line of anti-HER2-based therapy for LAI or metastatic disease. Prior anti-HER2 antibody-drug conjugate (ADC), such as tras [...] b emtansine (T-DM1), in any treatment setting. Participants for whomwithout prior ADC therapy wasmay only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not appropriatelocally (e.g.accessible at screening, [...]
Secondary endpointsdetails revised at 4 of 20 entries
2026-05-08
notable
Study Status, Contacts/Locations v4
Recruitment opened
Trial sites expanded: 0 → 4 locations
Primary completion pushed: 2029-03-30 → 2029-05-01
Completion pushed: 2032-08-28 → 2032-09-29
Start date2026-04-30→2026-06-01
2026-04-08
minor
3 amendments v1-v3
3 re-verifications since 2026-02-26, no change to tracked fields
2026-02-10
minor
Original filing
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.
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 2026-09-03