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RecruitingPhase 2NCT07102381

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

Sponsor

Jazz Pharmaceuticals

Enrollment

125 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

Breast CancerHER2-positive Breast Cancer

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding zanidatamab — a new type of HER2-targeting antibody — to standard chemotherapy before surgery helps women with HER2-positive breast cancer have better outcomes. **You may be eligible if...** - You have Stage II or III breast cancer that has been confirmed as HER2-positive - You have not yet had surgery and are planning to have a mastectomy or lumpectomy after treatment - Your heart function is in good shape (ejection fraction at least 50%) - Your overall health is good (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your breast cancer is HER2-negative - Your tumor has already been surgically removed - You have active heart disease or significant heart function problems - You have previously received treatment for this breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Administered intravenously (IV)

DRUGPaclitaxel

Administered intravenously (IV)

DRUGDocetaxel

Administered intravenously (IV)

DRUGCarboplatin

Administered intravenously (IV)

DRUGTrastuzumab

Administered intravenously (IV)

DRUGPertuzumab

Administered intravenously (IV)

Locations(26)

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

University of Wisconsin

Madison, Wisconsin, United States

Ospedale San Raffaele

Milan, Lombardy, Italy

Hospital Clínico San Cecilio

Granada, Andalusia, Spain

Álvaro Cunqueiro Hospital

Vigo, Galicia, Spain

Hosp Beata María Ana de Jesús

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07102381

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