NCT07413939

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

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-Postivie Breast Cancer, With or Without Central Nervous System Metastases

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	RO7771950	Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
DRUG	Tucatinib	Participants will receive a dose of tucatinib PO BID.
DRUG	Trastuzumab	Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
DRUG	Capecitabine	Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-03-30
• Completion: 2032-08-28
• First posted: 2026-02-17
• Last updated: 2026-04-09

Regulatory

• FDA-regulated drug study