Actively Recruiting
Phase 3 Study Comparing Zanidatamab Plus Chemotherapy With Trastuzumab Plus Chemotherapy for Adults With Metastatic HER2-positive Breast Cancer Who Have Progressed on or Cannot Tolerate Prior Trastuzumab Deruxtecan Treatment
Led by Jazz Pharmaceuticals · Updated on 2026-02-10
550
Participants Needed
166
Research Sites
129 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.
CONDITIONS
Brief Title
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
Research Team
C
Clinical Trial Disclosure & Transparency
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
