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RECRUITING
NCT07102381
PHASE2

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

Sponsor: Jazz Pharmaceuticals

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2025-09-24

Completion Date

2030-08-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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)

Locations (21)

Oncology Institute

Long Beach, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

The Oncology Institute

Lakeland, Florida, United States

Accellacare of McFarland

Ames, Iowa, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

New England Cancer Specialists

Scarborough, Maine, United States

Maryland Oncology Hematology

Laurel, Maryland, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Astera Cancer Care (Formerly Regional Cancer Care Associates)

East Brunswick, New Jersey, United States

Medical Oncology Hematology Associates

Newark, New Jersey, United States

Hematology Oncology Associates of Central New York

Camillus, New York, United States

Sarah Cannon Research Institute (Nashville)

Nashville, Tennessee, United States

Texas Oncology DFW

Dallas, Texas, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology Gulf Coast

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Shenandoah Oncology

Winchester, Virginia, United States

Northwest Medical Specialties

Puyallup, Washington, United States

Northwest Cancer Specialists

Vancouver, Washington, United States