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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.

Conditions

• Metastatic HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Zanidatamab	Administered by intravenous infusion
DRUG	Trastuzumab	Administered by intravenous infusion
DRUG	Eribulin	Administered by intravenous infusion
DRUG	Vinorelbine	Administered by intravenous infusion
DRUG	Gemcitabine	Administered by intravenous infusion
DRUG	Capecitabine	Given orally

Timeline

• Start date: 2024-08-13
• Primary completion: 2028-04-28
• Completion: 2030-10-18
• First posted: 2024-05-30
• Last updated: 2026-02-10

Locations

166 sites across 15 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study