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RecruitingPhase 3NCT06435429

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

Sponsor

Jazz Pharmaceuticals

Enrollment

550 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic HER2-positive Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a new antibody called zanidatamab works better than the standard drug trastuzumab (Herceptin) when combined with chemotherapy for HER2-positive breast cancer that has spread to other parts of the body. **You may be eligible if...** - You are 18 or older with HER2-positive breast cancer that cannot be removed by surgery or has spread (metastatic) - Your cancer has progressed on or you could not tolerate a prior drug called T-DXd (trastuzumab deruxtecan) - You have received at least 2 but no more than 4 prior HER2-targeted treatments for metastatic disease - Your heart function (ejection fraction) is at least 50% - You have a good performance level (able to carry out daily activities with minor limitations) **You may NOT be eligible if...** - You have active, uncontrolled brain spread (leptomeningeal disease) - You have significant heart disease or serious uncontrolled infections - You have HIV (unless well-controlled), active hepatitis B or C - You are pregnant or breastfeeding - You have had prior bone marrow or organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Administered by intravenous infusion

DRUGTrastuzumab

Administered by intravenous infusion

DRUGEribulin

Administered by intravenous infusion

DRUGVinorelbine

Administered by intravenous infusion

DRUGGemcitabine

Administered by intravenous infusion

DRUGCapecitabine

Given orally

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

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.

Padova, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06435429