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
Jazz Pharmaceuticals
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.
Description
Zanidatamab, as a monotherapy or in combination with other antineoplastic agents, has shown clinically meaningful efficacy against multiple HER2-positive advanced/metastatic tumors, including in patients with metastatic breast cancer (mBC). Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer. The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-rep…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent. 2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory 3. Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment. 4. Must have received at least 2 lines of HER2-directed therapy for their metastatic diseas…
Interventions
- DrugZanidatamab
Administered by intravenous infusion
- DrugTrastuzumab
Administered by intravenous infusion
- DrugEribulin
Administered by intravenous infusion
- DrugVinorelbine
Administered by intravenous infusion
- DrugGemcitabine
Administered by intravenous infusion
- DrugCapecitabine
Given orally
Locations (166)
- Mayo Clinic Scottsdale - PPDSPhoenix, Arizona
- Arizona Oncology Tucson - WilmotTucson, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- The Oncology Institute Of Hope And InnovationCerritos, California
- Los Angeles Hematology Oncology Medical Group GlendaleGlendale, California
- USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDSLos Angeles, California