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
NCT ID: NCT06435429
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2024-08-13
2031-11-26
Brief Summary
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Detailed Description
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The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zanidatamab plus physician's choice of chemotherapy
Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of zanidatamab plus physician's choice of chemotherapy (eribulin, or vinorelbine, or gemcitabine, or capecitabine).
Zanidatamab
Administered by intravenous infusion
Eribulin
Administered by intravenous infusion
Vinorelbine
Administered by intravenous infusion
Gemcitabine
Administered by intravenous infusion
Capecitabine
Given orally
Trastuzumab plus physician's choice of chemotherapy
Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of trastuzumab plus physician's choice of chemotherapy (eribulin, or gemcitabine, or vinorelbine, or capecitabine).
Trastuzumab
Administered by intravenous infusion
Eribulin
Administered by intravenous infusion
Vinorelbine
Administered by intravenous infusion
Gemcitabine
Administered by intravenous infusion
Capecitabine
Given orally
Interventions
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Zanidatamab
Administered by intravenous infusion
Trastuzumab
Administered by intravenous infusion
Eribulin
Administered by intravenous infusion
Vinorelbine
Administered by intravenous infusion
Gemcitabine
Administered by intravenous infusion
Capecitabine
Given orally
Eligibility Criteria
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Inclusion Criteria
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a 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. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. 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 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer:
* 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 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.
* 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.
14. 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 known or suspected leptomeningeal disease.
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 known HIV infection.
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. Was treated with any local or systemic antineoplastic therapy (including hormonal therapies for breast cancer) or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
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.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
IRCCS Centro di Riferimento Oncologico di Aviano CRO
Aviano, , Italy
Asst Papa Giovanni Xxiii
Bergamo, , Italy
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi Via Massarenti
Bologna, , Italy
Ospedale San Raffaele S.r.l PPDS
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliero Universitaria di Modena
Modena, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Chiba Cancer Center
Chiba, , Japan
National Cancer Center Hospital
Chūōku, , Japan
Osaka International Cancer Institute
Chūōku, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
Tokai University Hospital
Isesaki-shi, , Japan
Sagara Hospital
Kagoshima, , Japan
Kyoto University Hospital
Kyoto, , Japan
Aichi Cancer Center
Nagoya, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Showa University Hospital
Tokyo, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie w Białymstoku
Bialystok, , Poland
Wojewódzki Szpital Specjalistyczny W Białej Podlaskiej
Biała Podlaska, , Poland
Pratia MCM Kraków
Krakow, , Poland
Pratia Poznan
Poznan, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Warszawie
Warsaw, , Poland
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, , South Korea
Gachon University Gil Medical Center
Namdong-gu, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
ICO Badalona-H.U. Germans Trias i Pujol
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitario Clinico San Cecilio
Granada, , Spain
Hospital Beata Maria Ana
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, , Spain
Royal United Hospital
Bath, , United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Guy's Hospital
London, , United Kingdom
Charring Cross Hospital
London, , United Kingdom
The Christie - PPDS
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-508960-31-00
Identifier Type: OTHER
Identifier Source: secondary_id
JZP598-303
Identifier Type: -
Identifier Source: org_study_id
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