NCT07102381

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HER2-positive Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Zanidatamab	Administered intravenously (IV)
DRUG	Paclitaxel	Administered intravenously (IV)
DRUG	Docetaxel	Administered intravenously (IV)
DRUG	Carboplatin	Administered intravenously (IV)
DRUG	Trastuzumab	Administered intravenously (IV)
DRUG	Pertuzumab	Administered intravenously (IV)

Timeline

• Start date: 2025-09-24
• Primary completion: 2028-01-01
• Completion: 2030-08-01
• First posted: 2025-08-03
• Last updated: 2026-03-12

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study