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NCT07102381PHASE2Recruiting

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

Jazz Pharmaceuticals

Start Date

9/24/2025

Completion Date

8/1/2030

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma. 2. Has histologically confirmed HER2-positive breast cancer 3. Has a known hormone receptor (HR) status of the primary tumor 4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive. 5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function 8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization. 9. Adequate contraceptive precautions 10. Participants with known HIV are eligible unless: 1. CD4+ T Cell count is less than or equal to 350 microliters (uL) 2. Detectable viral load, or 3. Receiving protease inhibitors or cobicistat Exclusion Criteria: 1. Has Stage IV (metastatic) breast cancer. 2. Has bilateral breast cancer. 3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study. 4. Has uncontrolled hypertension 5. Has significant symptoms from peripheral neuropathy 6. Has an active uncontrolled infection 7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions. 8. Known active hepatitis B or C infection. 9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible. 10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer 11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol 12. Receipt of a live vaccine within 4 weeks prior to enrollment 13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy

Interventions

DRUG

Zanidatamab

DRUG

Paclitaxel

DRUG

Docetaxel

DRUG

Carboplatin

DRUG

Trastuzumab

DRUG

Pertuzumab

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Conditions

HER2-positive Breast CancerBreast Cancer

Locations

Oncology Institute

Long Beach, California 90805

United States

Cancer & Blood Research Center

Los Alamitos, California 90720

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Holy Cross Hospital

Fort Lauderdale, Florida 33308

United States

The Oncology Institute

Lakeland, Florida 33812

United States

Accellacare of McFarland

Ames, Iowa 50010

United States

LSU Health Sciences Center

Shreveport, Louisiana 71103

United States

New England Cancer Specialists

Scarborough, Maine 04074

United States

Maryland Oncology Hematology

Laurel, Maryland 20707

United States

Cancer Partners of Nebraska

Lincoln, Nebraska 68516

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68124

United States

Astera Cancer Care (Formerly Regional Cancer Care Associates)

East Brunswick, New Jersey 08816

United States

Medical Oncology Hematology Associates

Newark, New Jersey 19713

United States

The University of New Mexico

Albuquerque, New Mexico 87131

United States

Hematology Oncology Associates of Central New York

Camillus, New York 13031

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Levine Cancer

Charlotte, North Carolina 28204

United States

Sarah Cannon Research Institute (Nashville)

Nashville, Tennessee 37203

United States

Texas Oncology DFW

Dallas, Texas 75246

United States

The University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Texas Oncology Gulf Coast

Houston, Texas 77024

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Shenandoah Oncology

Winchester, Virginia 22601

United States

Northwest Medical Specialties

Puyallup, Washington 98373

United States

Northwest Cancer Specialists

Vancouver, Washington 98648

United States

University of Wisconsin

Madison, Wisconsin 53706

United States

Ospedale San Raffaele

Milan, Lombardy 20132

Italy

Hospital Clínico San Cecilio

Granada, Andalusia 18007

Spain

Álvaro Cunqueiro Hospital

Vigo, Galicia 36312

Spain

Hospital Universitario Vall d'Hebron

Barcelona, 0-8035

Spain

Hospital Universitario Clinico San Cecilio,

Granada, 18016

Spain

Hosp Beata María Ana de Jesús

Madrid, 28007

Spain