Zanidatamab in metastatic HER2-positive breast cancer participants
Research type
Research Study
Full title
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment
IRAS ID
1010111
Contact name
Kieran O'Donoghue
Contact email
Sponsor organisation
Jazz Pharmaceuticals Ireland Limited
Clinicaltrials.gov Identifier
Research summary
This will be a phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of
zanidatamab in combination with study doctor’s choice chemotherapy compared to trastuzumab in combination with
study doctor’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who
have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment.
Approximately 780 participants will be enrolled to achieve approximately 550 participants randomized 1:1 to zanidatamab or trastuzumab in this study. Eligible participants must have metastatic breast cancer that is HER2-positive that has progressed or has not been
able to tolerate treatment received with an anti-cancer medicine treatment.
Participants will be treated with zanidatamab or trastuzumab, both in combination with chemotherapy, in 3-week (21day) cycles.
Chemotherapy will be started on Day 1 of each cycle and administered according to best practices, and the starting dose, schedule, and mode of administration are per local regulations. Participants will be treated until disease progression, death, withdrawal of consent, the start of a new anticancer therapy, or request by the treating physician to discontinue treatment.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0142
Date of REC Opinion
5 Aug 2024
REC opinion
Further Information Favourable Opinion