drugset / Trial / NCT06435429

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

NCT06435429

Phase 3 Recruiting 550 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Timeline

Start
2024-08-13
Primary completion
2028-04-28
Completion
2030-10-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trastuzumab Monoclonal antibody Intravenous
Subject Zanidatamab Monoclonal antibody Intravenous
Background Capecitabine Small molecule Oral
Background Eribulin Small molecule Intravenous
Background Gemcitabine Small molecule Intravenous
Background Vinorelbine Small molecule Intravenous