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
A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent. 2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory 3. Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment. 4. Must have received at least 2 lines of HER2-directed therapy for their metastatic disease. 1. Prior HER2-targeted neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of the completion of therapy will be considered a line of treatment for metastatic disease. 2. Based on the physician's choice, participants' eligibility, and institutional and local guidelines, participants may also have received post-T-DXd therapy, for example, a tucatinib-based regimen and/or T-DM1. 3. Participants must not have received more than 4 lines of HER2-directed therapy in the metastatic setting. 5. Has measurable disease per RECIST version 1.1. 6. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine). 7. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol. 8. Has a life expectancy of at least 6 months, in the opinion of the investigator. 9. Has adequate hematologic parameters as defined in the protocol. 10. Has adequate hepatic function as specified in the protocol. 11. Has creatinine clearance ≥ 50 mL/minute as calculated per local institutional guidelines. 12. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention. 13. Has ECOG performance status of 0 or 1. 14. Participant agrees to the following based on sex assigned at birth. 1. Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 7 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice: * Refrain from donating fresh unwashed semen. * Use contraception as follows as specified in the protocol 2. Female participants: * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a women of nonchildbearing potential OR * Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency during the study intervention period and for at least 7 months after the last dose of study intervention. * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study intervention. * Additional requirements for pregnancy testing during and after study intervention are provided in the protocol. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 15. Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol. Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Has clinically confirmed leptomeningeal disease, in the opinion of the investigator. 2. Has uncontrolled or significant cardiovascular disease. 3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1, with exceptions as stated in the protocol. 4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 5. Has an infection with HIV-1 or HIV-2, with the exception of participants with well-controlled HIV. 6. Has active hepatitis B or C infection. 7. Has an active SARS-CoV-2 infection. Participants with prior infection that has resolved per local institutions' requirements and screening guidance are eligible. 8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab. 9. Is unable to receive trastuzumab treatment due to medical contraindications. 10. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site. 11. Has any condition that would prevent treatment with the physician's choice of chemotherapy. 12. Has any issue or condition that in the opinion of the investigator would contraindicate the participant's participation in the study or confound the results of the study. Prior/Concomitant Therapy 13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation. 14. The washout periods for prior anticancer therapies before randomization as specified in the protocol. 15. Has a history of trauma or major surgery within 4 weeks prior to randomization. Other Exclusions 16. Has a known hypersensitivity to any components of the study drugs, including chemotherapy. 17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
Study sites (48)
AZ
- Mayo Clinic Scottsdale - PPDS · Phoenix, AZ 85054More trials in Phoenix
- Arizona Oncology Tucson - Wilmot · Tucson, AZ 85711More trials in Tucson
- University of Arizona Cancer Center · Tucson, AZ 85719More trials in Tucson
CA
- The Oncology Institute Of Hope And Innovation · Cerritos, CA 90703More trials in Cerritos
- Los Angeles Hematology Oncology Medical Group Glendale · Glendale, CA 91204More trials in Glendale
- USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS · Los Angeles, CA 90033More trials in Los Angeles
- UCSF at Mission Bay MB · San Francisco, CA 94158More trials in San Francisco
CO
- University of Colorado-Cancer Center-PPDS · Aurora, CO 80045-2517More trials in Aurora
- Rocky Mountain Cancer Centers · Denver, CO 80218More trials in Denver
DC
- Medstar Georgetown University Hospital · Washington D.C., DC 20007More trials in Washington D.C.
- Washington Cancer Center · Washington D.C., DC 20010More trials in Washington D.C.
FL
- Florida Cancer Specialists Research South · Fort Myers, FL 33901More trials in Fort Myers
- Mayo Clinic Jacksonville - PPDS · Jacksonville, FL 32224More trials in Jacksonville
- Florida Cancer Specialists Research North · St. Petersburg, FL 33705More trials in St. Petersburg
- Florida Cancer Specialists Research East · West Palm Beach, FL 33401More trials in West Palm Beach
MA
- Dana Farber Cancer Institute · Boston, MA 02215-5418More trials in Boston
MN
- Minnesota Oncology Hematology · Coon Rapids, MN 55433More trials in Coon Rapids
- Mayo Clinic - PPDS · Rochester, MN 55905More trials in Rochester
MO
- Saint Luke's Cancer Institute · Kansas City, MO 64111More trials in Kansas City
NC
- Messino Cancer Center · Asheville, NC 28806More trials in Asheville
- Duke Cancer Institute · Durham, NC 27710-2000More trials in Durham
- UNC Central Investigational Drug Services · Morrisville, NC 27560More trials in Morrisville
NJ
- Hackensack Meridian Health · Hackensack, NJ 07601More trials in Hackensack
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08901More trials in New Brunswick
NY
- Memorial Sloan Kettering · Long Island City, NY 11101More trials in Long Island City
- Perlmutter Cancer Center 160 E 34th St · New York, NY 10016-4744More trials in New York
- The Mount Sinai Hospital · New York, NY 10029More trials in New York
- Columbia University Medical Center 161 Fort Washington · New York, NY 10032-3729More trials in New York
OH
- Oncology Hematology Care (OHC) · Cincinnati, OH 45226More trials in Cincinnati
- University Hospitals Cleveland Medical Center 11100 Euclid Ave · Cleveland, OH 44106-1716More trials in Cleveland
PA
- Abramson Cancer Center of The University of Pennsylvania · Philadelphia, PA 19104More trials in Philadelphia
- Fox Chase Cancer Center · Philadelphia, PA 19111More trials in Philadelphia
RI
- Rhode Island Hospital · Providence, RI 02903More trials in Providence
TN
- Sarah Cannon Research Institute · Nashville, TN 37203More trials in Nashville
TX
- Texas Oncology - Fort Worth · Fort Worth, TX 76104More trials in Fort Worth
- U.T. MD Anderson Cancer Center, Investigational Pharmacy Services · Houston, TX 77030More trials in Houston
- Millennium Research and Clinical Development · Houston, TX 77090More trials in Houston
- Maryland Oncology Hematology Healing Way - USOR · Irving, TX 75063More trials in Irving
- Medical Oncology Hematology Consultants · Irving, TX 75063More trials in Irving
- Nexus Health · Irving, TX 75063More trials in Irving
- Sansum Clinic 540 W - USOR · Irving, TX 75063More trials in Irving
- Texas Oncology Gulf Coast · Irving, TX 75063More trials in Irving
- Texas Oncology West · Irving, TX 75063More trials in Irving
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax
- Virginia Oncology Associates, Sentara Health · Norfolk, VA 23502More trials in Norfolk
- Blue Ridge Cancer Care · Roanoke, VA 24014More trials in Roanoke
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109More trials in Seattle
WI
- Froedtert and The Medical College of Wisconsin · Milwaukee, WI 53226More trials in Milwaukee