A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
NCT07102381 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2026-04-29
Summary
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
Conditions
Interventions
- DRUG
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
- DRUG
-
Administered intravenously (IV)
Sponsors & Collaborators
-
Jazz Pharmaceuticals Ireland Limited
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-24
- Primary Completion
- 2028-01-01
- Completion
- 2030-08-01
- FDA Drug
- Yes
Countries
- United States
- Italy
- Spain
Study Locations
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