AzTrials
AzTrials

Metastatic HER2-positive Breast CancerPhase 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 study testing Zanidatamab, Trastuzumab and Eribulin in people with Metastatic HER2-positive Breast Cancer, run by Jazz Pharmaceuticals at 166 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic HER2-positive Breast Cancer
What is being tested?
Zanidatamab, Trastuzumab and Eribulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
166 sitesin 15 countries
Study dates
13 Aug 2024to 18 Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  5. 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.
  6. 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.
  7. Participants must not have received more than 4 lines of HER2-directed therapy in the metastatic setting.
  8. Has measurable disease per RECIST version 1.1.
  9. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
  10. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol.
  11. Has a life expectancy of at least 6 months, in the opinion of the investigator.
  12. Has adequate hematologic parameters as defined in the protocol.
  13. Has adequate hepatic function as specified in the protocol.
  14. Has creatinine clearance ≥ 50 mL/minute as calculated per local institutional guidelines.
  15. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention.
  16. Has ECOG performance status of 0 or 1.
  17. Participant agrees to the following based on sex assigned at birth.
  18. 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
  1. 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.
  1. 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.

Trial locations and contacts

166 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

166 sites in 15 countries

United States48 sites, 45 recruiting

  • Messino Cancer Center

    Asheville, North Carolina, 28806

    Recruiting

  • University of Colorado-Cancer Center-PPDS

    Aurora, Colorado, 80045-2517

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

    Recruiting

  • The Oncology Institute Of Hope And Innovation

    Cerritos, California, 90703

    Recruiting

  • Oncology Hematology Care (OHC)

    Cincinnati, Ohio, 45226

    Recruiting

  • University Hospitals Cleveland Medical Center 11100 Euclid Ave

    Cleveland, Ohio, 44106-1716

    Withdrawn

  • Minnesota Oncology Hematology

    Coon Rapids, Minnesota, 55433

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710-2000

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists Research South

    Fort Myers, Florida, 33901

    Recruiting

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Los Angeles Hematology Oncology Medical Group Glendale

    Glendale, California, 91204

    Recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Recruiting

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

    Houston, Texas, 77030

    Recruiting

  • Millennium Research and Clinical Development

    Houston, Texas, 77090

    Withdrawn

  • Maryland Oncology Hematology Healing Way - USOR

    Irving, Texas, 75063

    Recruiting

  • Medical Oncology Hematology Consultants

    Irving, Texas, 75063

    Recruiting

  • Nexus Health

    Irving, Texas, 75063

    Recruiting

  • Sansum Clinic 540 W - USOR

    Irving, Texas, 75063

    Recruiting

  • Texas Oncology Gulf Coast

    Irving, Texas, 75063

    Recruiting

  • Texas Oncology West

    Irving, Texas, 75063

    Recruiting

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida, 32224

    Recruiting

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

    Recruiting

  • Memorial Sloan Kettering

    Long Island City, New York, 11101

    Recruiting

  • USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS

    Los Angeles, California, 90033

    Recruiting

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • UNC Central Investigational Drug Services

    Morrisville, North Carolina, 27560

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Perlmutter Cancer Center 160 E 34th St

    New York, New York, 10016-4744

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Recruiting

  • Columbia University Medical Center 161 Fort Washington

    New York, New York, 10032-3729

    Recruiting

  • Virginia Oncology Associates, Sentara Health

    Norfolk, Virginia, 23502

    Recruiting

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Mayo Clinic Scottsdale - PPDS

    Phoenix, Arizona, 85054

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Recruiting

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

    Recruiting

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905

    Recruiting

  • UCSF at Mission Bay MB

    San Francisco, California, 94158

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Florida Cancer Specialists Research North

    St. Petersburg, Florida, 33705

    Recruiting

  • Arizona Oncology Tucson - Wilmot

    Tucson, Arizona, 85711

    Withdrawn

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Recruiting

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Recruiting

  • Washington Cancer Center

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Florida Cancer Specialists Research East

    West Palm Beach, Florida, 33401

    Recruiting

Other trials in United States

Japan17 sites, 17 recruiting

  • Chiba Cancer Center

    Chiba, 260-8717

    Recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    Recruiting

  • Osaka International Cancer Institute

    Chūōku, 541-8567

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka-shi, 350-1298

    Recruiting

  • Tokai University Hospital

    Isesaki-shi, 259-1193

    Recruiting

  • Sagara Hospital

    Kagoshima, 892-0833

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Recruiting

  • Aichi Cancer Center

    Nagoya, 464-8681

    Recruiting

  • Nagoya City University Hospital

    Nagoya, 467-8602

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

    Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431

    Recruiting

  • Showa University Hospital

    Tokyo, 142-8666

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515

    Recruiting

Other trials in Japan

Spain16 sites, 16 recruiting

  • Hospital Universitario A Coruña

    A Coruña, 15006

    Recruiting

  • Hospital Universitario de Badajoz

    Badajoz, 06006

    Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • ICO Badalona-H.U. Germans Trias i Pujol

    Barcelona, 08916

    Recruiting

  • Hospital General Universitario de Elche

    Elche, 03203

    Recruiting

  • Hospital Universitario Clinico San Cecilio

    Granada, 18016

    Recruiting

  • Hospital Beata Maria Ana

    Madrid, 28007

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, 36312

    Recruiting

Other trials in Spain

Brazil12 sites, 12 recruiting

  • DASA Hospital Brasilia

    Brasília, 71.635-610

    Recruiting

  • Centro Regional Integrado de Oncologia

    Ceará, 60336-232

    Recruiting

  • Catarina Pesquisa Clinica

    Itajaí, 88301-220

    Recruiting

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Portalegre, 90050-170

    Recruiting

  • Hospital Nossa Senhora Da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

    Recruiting

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

    Porto Alegre, 90610-001

    Recruiting

  • Real Hospital Portugues de Beneficiencia Em Pernambuco

    Recife, 52.010-075

    Recruiting

  • Nucleo de Oncologia Da Bahia

    Salvador, 40.170-070

    Recruiting

  • Ceon Pesquisas Ltda

    São Caetano do Sul, 09541-270

    Recruiting

  • Hospital Beneficiencia Portuguesa

    São Paulo, 01323-030

    Recruiting

  • Onco Star Sp Oncologia LTDA

    São Paulo, 04062-001

    Recruiting

  • IEPE Unimed Sorocaba

    Sorocaba, São Paulo, 18060-105

    Recruiting

Other trials in Brazil

France11 sites, 11 recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21000

    Recruiting

  • Pharmacie Centre de Cancerologie de la Sarthe

    Le Mans, 72000

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Recruiting

  • AP HM Hopital de La Timone

    Marseille, 13005

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Recruiting

  • Pharmacie ICM Val d'Aurelle

    Montpellier, 34298

    Recruiting

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, 67000

    Recruiting

  • Oncopôle Claudius Regaud Pharmacie

    Toulouse, 31059

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Italy11 sites, 11 recruiting

  • IRCCS Centro di Riferimento Oncologico di Aviano CRO

    Aviano, 33081

    Recruiting

  • Asst Papa Giovanni Xxiii

    Bergamo, 24127

    Recruiting

  • Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi Via Massarenti

    Bologna, 40138

    Recruiting

  • Ospedale San Raffaele S.r.l PPDS

    Milan, 20132

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41124

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

    Recruiting

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, 35128

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00136

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

South Korea8 sites, 8 recruiting

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan-si, 330721

    Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, 21565

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 137-701

    Recruiting

Other trials in South Korea

United Kingdom8 sites, 8 recruiting

  • Royal United Hospital

    Bath, BA1 3NG

    Recruiting

  • Beatson West Of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • Leicester Royal Infirmary

    Leicester, LE2 7LX

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    Recruiting

  • Charring Cross Hospital

    London, W6 8RF

    Recruiting

  • The Christie - PPDS

    Manchester, M20 4BX

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LJ

    Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP

    Recruiting

Other trials in United Kingdom

Australia6 sites, 6 recruiting

  • HPS Pharmacies - Adelaide

    Adelaide, 5000

    Recruiting

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

    Recruiting

  • Box Hill Hospital

    Melbourne, Victoria, 3128

    Recruiting

  • The Kinghorn Cancer Centre

    Mount Kuring-Gai, 2080

    Recruiting

  • Peninsula and South Eastern Haematology and Oncology Group

    Mount Waverly, Victoria, 3149

    Recruiting

  • St John of God Hospital Subiaco

    Subiaco, 6008

    Recruiting

Other trials in Australia

Poland6 sites, 6 recruiting

  • Wojewódzki Szpital Specjalistyczny W Białej Podlaskiej

    Biała Podlaska, 21-500

    Recruiting

  • Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie w Białymstoku

    Bialystok, 15-027

    Recruiting

  • Pratia MCM Kraków

    Krakow, 30-727

    Recruiting

  • Pratia Poznan

    Poznan, 60-192

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Warszawie

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Belgium5 sites, 5 recruiting

  • Institute Jules Bordet

    Anderlecht, 1070

    Recruiting

  • UZ Antwerpen

    Edegem, 2650

    Recruiting

  • Grand Hôpital de Charleroi

    Gilly, 6060

    Recruiting

  • CHU UCL Namur - Site Sainte-Elisabeth

    Namur, 5000

    Recruiting

  • AZ Delta- Campus Rumbeke

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Canada5 sites, 5 recruiting

  • Jewish General Hospital

    Montreal, H3T 1E2

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6

    Recruiting

  • CHU de Québec Université Laval Hôpital du Saint Sacrement

    Québec, G1S 4L8

    Recruiting

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

    Recruiting

  • BC Cancer-Vancouver Center

    Vancouver, V5Z 4E6

    Recruiting

Other trials in Canada

Germany5 sites, 5 recruiting

  • Helios Klinikum Berlin Buch GmbH Klinik für Gynäkologie und Geburtshilfe

    Berlin, 13125

    Recruiting

  • Marienhospital Bottrop gGmbH

    Dortmund, 44263

    Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden, 01307

    Recruiting

  • LMU Klinikum - Apotheke

    München, 81377

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

Austria4 sites, 4 recruiting

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

    Recruiting

  • Ordensklinikum Barmherzige Schwestern

    Linz, 4010

    Recruiting

  • Medizinische Universitat Wien

    Vienna, 1090

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH - Abteilung für Innere Medizin IV

    Wels, 4600

    Recruiting

Other trials in Austria

Greece4 sites, 4 recruiting

  • Aretaieio Hospital

    Athens, 11528

    Recruiting

  • Athens Medical Center

    Athens, 15125

    Recruiting

  • University General Hospital of Patras

    Pátrai, 26504

    Recruiting

  • European Interbalkan Medical Center

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

About this study

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

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.

Read the detailed description

Zanidatamab, as a monotherapy or in combination with other antineoplastic agents, has shown clinically meaningful efficacy against multiple HER2-positive advanced/metastatic tumors, including in patients with metastatic breast cancer (mBC). Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer.

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.

Being tested
Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Keywords
Zanidatamab, Trastuzumab, Metastatic HER2-positive breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanidatamabDrug

    Administered by intravenous infusion

  • TrastuzumabDrug

    Administered by intravenous infusion

  • EribulinDrug

    Administered by intravenous infusion

  • VinorelbineDrug

    Administered by intravenous infusion

  • GemcitabineDrug

    Administered by intravenous infusion

  • CapecitabineDrug

    Given orally

Study groups in NCT06435429
Study groupRoleWhat they receive
Zanidatamab plus physician's choice of chemotherapyExperimentalParticipants 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).
Receives: Drug: Zanidatamab; Drug: Eribulin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Capecitabine
Trastuzumab plus physician's choice of chemotherapyActive comparatorParticipants 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).
Receives: Drug: Trastuzumab; Drug: Eribulin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Until disease progression or death, up to approximately 44 months

Secondary outcomes (14)

  1. Overall Survival (OS)

    OS is defined as the time in months from randomization to the date of death due to any cause.

    Measured: Until death, up to approximately 80 months

  2. Confirmed Objective Response Rate (ORR) Per RECIST Version 1.1, As Assessed by BICR

    The BICR-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of BICR-assessed Complete Response (CR) or Partial Response (PR) after randomization.

    Measured: Until disease progression or death, up to approximately 44 months

  3. Duration of Response (DOR) Per RECIST Version 1.1, As Assessed by BICR

    BICR-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) as assessed by BICR per RECIST v1.1 or death from any cause.

    Measured: Until disease progression or death, up to approximately 44 months

  4. PFS Per RECIST Version 1.1, As Assessed By Investigator

    Investigator-assessed PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by investigator according to RECIST v1.1) or death from any cause, whichever occurs first

    Measured: Until disease progression or death, up to approximately 44 months

  5. Confirmed ORR Per RECIST Version 1.1, As Assessed By Investigator

    The investigator-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of investigator-assessed confirmed CR or PR after randomization.

    Measured: Until disease progression or death, up to approximately 44 months

  6. DOR Per RECIST Version 1.1, As Assessed By Investigator

    Investigator-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented PD as assessed by the investigator per RECIST v1.1 or death from any cause.

    Measured: Until disease progression or death, up to approximately 44 months

  7. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events As Graded by NCI CTCAE Version 5.0

    Measured: Up to approximately 44 months

  8. Number of Participants With Dose Reductions

    Measured: Up to approximately 44 months

  9. Number of Participants Discontinuing Study Treatment Due to TEAEs

    Measured: Up to approximately 44 months

  10. Serum Concentrations of Zanidatamab

    Measured: Up to approximately 44 months

  11. Number of Participants Positive for Anti-drug Antibodies to Zanidatamab

    Measured: Up to approximately 44 months

  12. Proportion of All Treated Participants, As Treated, Reporting Symptomatic Adverse Events While On Treatment Based on Patient-reported Outcome-Common Terminology Criteria for AEs and European Organisation for Research and Treatment of Cancer Item Library

    Measured: Up to approximately 44 months

  13. Proportion of All Treated Participants, As Treated, Reporting Overall Side-effect Bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)

    The Functional Assessment of Chronic Illness Therapy (FACIT) GP5 Item score ranges from 0 (Not at all) to 4 (Very Much), where higher scores reflect greater bother from treatment side effects.

    Measured: Up to approximately 44 months

  14. Proportion of Treated Participants, As Treated, With Maintained or Improved Physical Function While On Treatment Based On The Physical Functioning Subscale of the EORTC Quality of Life Questionnaire Core Module (EORTC QLQ-C30)

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core Module Physical Functioning score ranges from 0 to 100, where higher scores reflect better functioning.

    Measured: Up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start13 Aug 2024
  3. Primary completion28 Apr 2028 (estimated)
  4. Study completion18 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435429
Sponsor's protocol ID
JZP598-303
Other IDs
2023-508960-31-00, 2023
Status last verified
Feb 2026
First submitted
24 May 2024
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zanidatamab, Trastuzumab and Eribulin in people with Metastatic HER2-positive Breast Cancer, run by Jazz Pharmaceuticals at 166 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Japan, Spain, Brazil, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR) (time frame: Until disease progression or death, up to approximately 44 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06435429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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