Study Comparing RO7771950 and Tucatinib, Each with Trastuzumab and Capecitabine, for Advanced or Metastatic HER2-Positive Breast Cancer Including Brain Metastases

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the drug RO7771950 combined with trastuzumab and capecitabine compared to tucatinib combined with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. This study includes patients with or without central nervous system metastases and focuses on those who have previously received anti-HER2 therapies. The trial is a randomized, open-label study sponsored by Hoffmann-La Roche, designed to assess treatment outcomes in this patient population. Participants will be assigned to one of three groups two experimental arms receiving different doses of RO7771950 orally twice daily, or a comparator arm receiving tucatinib orally twice daily. All participants will also receive trastuzumab, administered either intravenously or subcutaneously according to local guidelines, and capecitabine taken orally twice daily. The study evaluates these treatments over an extended period to monitor their effects on disease progression and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, evaluations of heart function, and monitoring of symptoms and quality of life. Researchers will track progression-free survival as the primary outcome, along with secondary measures such as overall survival, response rates, treatment-related side effects, and patient-reported outcomes. The total study duration may extend up to several years to capture long-term results and safety data.

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