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RECRUITING

NCT06435429

PHASE3

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

Sponsor: Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2024-08-13

Completion Date

2030-10-18

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Metastatic HER2-positive Breast Cancer

Interventions

DRUG

Zanidatamab

Administered by intravenous infusion

DRUG

Trastuzumab

Administered by intravenous infusion

DRUG

Eribulin

Administered by intravenous infusion

DRUG

Vinorelbine

Administered by intravenous infusion

DRUG

Gemcitabine

Administered by intravenous infusion

DRUG

Capecitabine

Given orally

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.

Locations (166)

Mayo Clinic Scottsdale - PPDS

Phoenix, Arizona, United States

Arizona Oncology Tucson - Wilmot

Tucson, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

The Oncology Institute Of Hope And Innovation

Cerritos, California, United States

Los Angeles Hematology Oncology Medical Group Glendale

Glendale, California, United States

USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS

Los Angeles, California, United States

UCSF at Mission Bay MB

San Francisco, California, United States

University of Colorado-Cancer Center-PPDS

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Medstar Georgetown University Hospital

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

Washington Cancer Center

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

Florida Cancer Specialists Research South

Fort Myers, Florida, United States

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, United States

Florida Cancer Specialists Research North

St. Petersburg, Florida, United States

Florida Cancer Specialists Research East

West Palm Beach, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Minnesota Oncology Hematology

Coon Rapids, Minnesota, United States

Mayo Clinic - PPDS

Rochester, Minnesota, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan Kettering

Long Island City, New York, United States

Perlmutter Cancer Center 160 E 34th St

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Columbia University Medical Center 161 Fort Washington

New York, New York, United States

Messino Cancer Center

Asheville, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

UNC Central Investigational Drug Services

Morrisville, North Carolina, United States

Oncology Hematology Care (OHC)

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center 11100 Euclid Ave

Cleveland, Ohio, United States

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology - Fort Worth

Fort Worth, Texas, United States

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

Houston, Texas, United States

Millennium Research and Clinical Development

Houston, Texas, United States

Maryland Oncology Hematology Healing Way - USOR

Irving, Texas, United States

Medical Oncology Hematology Consultants

Irving, Texas, United States

Nexus Health

Irving, Texas, United States

Sansum Clinic 540 W - USOR

Irving, Texas, United States

Texas Oncology Gulf Coast

Irving, Texas, United States

Texas Oncology West

Irving, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates, Sentara Health

Norfolk, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

Box Hill Hospital

Melbourne, Victoria, Australia

Peninsula and South Eastern Haematology and Oncology Group

Mount Waverly, Victoria, Australia

HPS Pharmacies - Adelaide

Adelaide, Australia

The Kinghorn Cancer Centre

Mount Kuring-Gai, Australia

St John of God Hospital Subiaco

Subiaco, Australia

Medizinische Universitat Innsbruck

Innsbruck, Austria

Ordensklinikum Barmherzige Schwestern

Linz, Austria

Medizinische Universitat Wien

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH - Abteilung für Innere Medizin IV

Wels, Austria

Institute Jules Bordet

Anderlecht, Belgium

UZ Antwerpen

Edegem, Belgium

Grand Hôpital de Charleroi

Gilly, Belgium

CHU UCL Namur - Site Sainte-Elisabeth

Namur, Belgium

AZ Delta- Campus Rumbeke

Roeselare, Belgium

Hospital Nossa Senhora Da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

IEPE Unimed Sorocaba

Sorocaba, São Paulo, Brazil

DASA Hospital Brasilia

Brasília, Brazil

Centro Regional Integrado de Oncologia

Ceará, Brazil

Catarina Pesquisa Clinica

Itajaí, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Portalegre, Brazil

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul PUCRS

Porto Alegre, Brazil

Real Hospital Portugues de Beneficiencia Em Pernambuco

Recife, Brazil

Nucleo de Oncologia Da Bahia

Salvador, Brazil

Ceon Pesquisas Ltda

São Caetano do Sul, Brazil

Hospital Beneficiencia Portuguesa

São Paulo, Brazil

Onco Star Sp Oncologia LTDA

São Paulo, Brazil

Jewish General Hospital

Montreal, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Canada

CHU de Québec Université Laval Hôpital du Saint Sacrement

Québec, Canada

Sunnybrook Research Institute

Toronto, Canada

BC Cancer-Vancouver Center

Vancouver, Canada

Institut Bergonie

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Georges François Leclerc

Dijon, France

Pharmacie Centre de Cancerologie de la Sarthe

Le Mans, France

Centre Oscar Lambret

Lille, France

AP HM Hopital de La Timone

Marseille, France

Institut Paoli Calmettes

Marseille, France

Pharmacie ICM Val d'Aurelle

Montpellier, France

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France

Oncopôle Claudius Regaud Pharmacie

Toulouse, France

Gustave Roussy

Villejuif, France

Helios Klinikum Berlin Buch GmbH Klinik für Gynäkologie und Geburtshilfe

Berlin, Germany

Marienhospital Bottrop gGmbH

Dortmund, Germany

Universitätsklinikum Carl Gustav Carus an der TU

Dresden, Germany

LMU Klinikum - Apotheke

München, Germany

Universitätsklinikum Ulm

Ulm, Germany

Aretaieio Hospital

Athens, Greece

Athens Medical Center

Athens, Greece

University General Hospital of Patras

Pátrai, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

And 66 more locations on ClinicalTrials.gov