A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

NCT06435429

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Led by Jazz Pharmaceuticals · Updated on 2026-02-10

550

Participants Needed

166

Research Sites

322 weeks

Total Duration

AI-Summary

What this Trial Is About

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

CONDITIONS

Official Title

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be 18 years of age or older at the time of informed consent
Have histologically confirmed HER2-positive breast cancer per ASCO-CAP guidelines
Have unresectable or metastatic HER2-positive breast cancer that progressed on or is intolerant to prior trastuzumab deruxtecan (T-DXd) treatment
Have received at least 2 lines of HER2-directed therapy for metastatic disease, but no more than 4 lines
Have measurable disease per RECIST version 1.1
Be eligible to receive one of the chemotherapy options: eribulin, gemcitabine, vinorelbine, or capecitabine
Have history of treated or clinically inactive central nervous system metastases as specified in the protocol
Have a life expectancy of at least 6 months as judged by the investigator
Have adequate blood counts and liver function as defined in the protocol
Have creatinine clearance of at least 50 mL/min
Have left ventricular ejection fraction (LVEF) of 50% or higher measured by echocardiogram or MUGA within 4 weeks before first dose
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Agree to contraception requirements during and after the study based on sex assigned at birth
Be able to give signed informed consent and comply with study requirements

You will not qualify if you...

Have clinically confirmed leptomeningeal disease
Have uncontrolled or significant cardiovascular disease
Have unresolved toxicity from prior cancer therapy greater than Grade 1 except as allowed
Have uncontrolled infection needing intravenous antibiotics, antivirals, or antifungals
Have active HIV infection not well controlled
Have active hepatitis B or C infection
Have active SARS-CoV-2 infection
Have history of life-threatening hypersensitivity to monoclonal antibodies or components of zanidatamab
Be unable to receive trastuzumab due to medical reasons
Have serious medical or psychiatric conditions impairing treatment tolerance or study participation
Have conditions preventing chemotherapy treatment
Have history of prior allogeneic bone marrow, stem cell, or solid organ transplant
Have recent trauma or major surgery within 4 weeks before randomization
Have known hypersensitivity to study drugs or chemotherapy components
Are pregnant, breastfeeding, or planning pregnancy during the study period

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Trial Site Locations

Total: 166 locations

Mayo Clinic Scottsdale - PPDS

Phoenix, Arizona, United States, 85054

Actively Recruiting

Arizona Oncology Tucson - Wilmot

Tucson, Arizona, United States, 85711

Withdrawn

University of Arizona Cancer Center

Tucson, Arizona, United States, 85719

Actively Recruiting

The Oncology Institute Of Hope And Innovation

Cerritos, California, United States, 90703

Actively Recruiting

Los Angeles Hematology Oncology Medical Group Glendale

Glendale, California, United States, 91204

Actively Recruiting

USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS

Los Angeles, California, United States, 90033

Actively Recruiting

UCSF at Mission Bay MB

San Francisco, California, United States, 94158

Actively Recruiting

University of Colorado-Cancer Center-PPDS

Aurora, Colorado, United States, 80045-2517

Actively Recruiting

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

Actively Recruiting

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

Washington Cancer Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

Florida Cancer Specialists Research South

Fort Myers, Florida, United States, 33901

Actively Recruiting

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States, 32224

Actively Recruiting

Florida Cancer Specialists Research North

St. Petersburg, Florida, United States, 33705

Actively Recruiting

Florida Cancer Specialists Research East

West Palm Beach, Florida, United States, 33401

Actively Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

Minnesota Oncology Hematology

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

Mayo Clinic - PPDS

Rochester, Minnesota, United States, 55905

Actively Recruiting

Saint Luke's Cancer Institute

Kansas City, Missouri, United States, 64111

Actively Recruiting

Hackensack Meridian Health

Hackensack, New Jersey, United States, 07601

Actively Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

Memorial Sloan Kettering

Long Island City, New York, United States, 11101

Actively Recruiting

Perlmutter Cancer Center 160 E 34th St

New York, New York, United States, 10016-4744

Actively Recruiting

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

Columbia University Medical Center 161 Fort Washington

New York, New York, United States, 10032-3729

Actively Recruiting

Messino Cancer Center

Asheville, North Carolina, United States, 28806

Actively Recruiting

Duke Cancer Institute

Durham, North Carolina, United States, 27710-2000

Actively Recruiting

UNC Central Investigational Drug Services

Morrisville, North Carolina, United States, 27560

Actively Recruiting

Oncology Hematology Care (OHC)

Cincinnati, Ohio, United States, 45226

Actively Recruiting

University Hospitals Cleveland Medical Center 11100 Euclid Ave

Cleveland, Ohio, United States, 44106-1716

Withdrawn

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

Texas Oncology - Fort Worth

Fort Worth, Texas, United States, 76104

Actively Recruiting

U.T. MD Anderson Cancer Center, Investigational Pharmacy Services

Houston, Texas, United States, 77030

Actively Recruiting

Millennium Research and Clinical Development

Houston, Texas, United States, 77090

Withdrawn

Maryland Oncology Hematology Healing Way - USOR