Study of Zanidatamab for Metastatic HER2-positive Breast Cancer

This study is comparing two treatments for metastatic HER2-positive breast cancer. You may be able to join if you are 18 or older, have HER2-positive breast cancer that has spread, and your cancer has progressed after or you couldn't tolerate previous T-DXd treatment. The study is testing zanidatamab combined with your doctor's choice of chemotherapy against trastuzumab (another drug) also with your doctor's choice of chemotherapy. Researchers want to see if zanidatamab is more effective at stopping the cancer from growing or spreading (progression-free survival) and to understand its safety. The study plans to enroll about 550 participants.

Study design
This study is comparing two treatment combinations for metastatic HER2-positive breast cancer. It plans to include about 550 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until their disease progresses or they pass away, for up to approximately 44 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Jazz Pharmaceuticals
~550 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:ZanidatamabTrastuzumabEribulinVinorelbineGemcitabineCapecitabine

At a glance

Recruiting sites
163 of 166 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)
Measured over Until disease progression or death, up to approximately 44 months
Metastatic HER2-positive Breast Cancer
166 sites across 37 states
Japan17
Spain16
France11
Italy11
Brazil10
Texas9
South Korea8
United Kingdom8
Clinical Trial Disclosure & Transparency
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  • Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)Until disease progression or death, up to approximately 44 months

    PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.