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Looking for participantsPhase3

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

NCT ID: NCT06435429

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zanidatamab (drug), Trastuzumab (drug), Eribulin (drug), Vinorelbine (drug)
How long the study runs
Study runs about 74 months (dates as stated)
About the drug or intervention
Zanidatamab — drug: Administered by intravenous infusion · Trastuzumab — drug: Administered by intravenous infusion · Eribulin — drug: Administered by intravenous infusion · Vinorelbine — drug: Administered by intravenous infusion · Gemcitabine — drug: Administered by intravenous infusion · Capecitabine — drug: Given orally
Patient visit burden
Not specified by the sponsor

In plain English

This study compares two drugs, zanidatamab and trastuzumab (also called Herceptin), for adults with metastatic HER2-positive breast cancer. HER2-positive means the cancer has a protein that makes it grow. Both drugs are given together with a chemotherapy chosen by the doctor.

Who can take part

  • Adults aged 18 or over
  • Have HER2-positive breast cancer confirmed by a central laboratory test
  • Have breast cancer that has spread or cannot be removed by surgery, and previous treatment with T-DXd stopped working or caused bad side effects
  • Have had at least 2 but no more than 4 courses of HER2 treatment for metastatic cancer
  • Have cancer that can be measured on scans
  • Are able to have one of the chemotherapy drugs offered (eribulin, gemcitabine, vinorelbine or capecitabine)
  • May have cancer spread to the brain if it has been treated or is not active
  • Are expected to live at least 6 months
  • Have healthy enough blood, liver and kidney function (as set out in the study plan)
  • Have a heart pumping function (LVEF, a measure of how well the heart pumps) of 50% or more on a recent heart scan
  • Are well enough to care for themselves, with only limited physical activity at most (ECOG score of 0 or 1)
  • Are not pregnant or breastfeeding, and agree to use contraception during the study and for at least 7 months after the last dose
  • Are able to give informed consent and follow the study rules

Who may not be able to

  • Cancer spread to the tissues covering the brain and spinal cord (leptomeningeal disease)
  • Heart disease that is not controlled or is severe
  • Side effects from earlier cancer treatment that have not mostly gone away
  • Infection needing treatment through a drip that is not controlled
  • HIV that is not well controlled
  • Active hepatitis B or hepatitis C infection
  • Current COVID-19 infection
  • Life-threatening allergic reaction in the past to monoclonal antibodies (a type of drug made in a lab) or to ingredients in zanidatamab
  • Cannot have trastuzumab for medical reasons
  • A serious medical or mental health problem that would make taking part too hard
  • Anything that would prevent chemotherapy treatment
  • Past bone marrow, stem cell or organ transplant from a donor
  • Have not waited the required time after earlier cancer treatment before joining
  • Major surgery or injury in the 4 weeks before joining
  • Allergy to any of the study drugs, including chemotherapy
  • Pregnant, breastfeeding, or planning a pregnancy

What taking part involves

  • • Being given either zanidatamab or trastuzumab — which one you get is decided by chance
  • • Receiving one chemotherapy drug chosen by your doctor: eribulin, gemcitabine, vinorelbine or capecitabine

Time commitment: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
550
Started
2024-08-13
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic her2-positive breast cancer
  • • Phase3 - 550 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic her2-positive breast cancer

Where?

  • • Bath - Royal United Hospital
  • • Glasgow - Beatson West Of Scotland Cancer Centre
  • • Leicester - Leicester Royal Infirmary
  • • London - Guy's Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Metastatic HER2-positive Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

HER2HER2 positivehave a negative

Treatment history

Treatments you must have had:

  • ✓ received at least 2 lines of HER2-directed therapy for their metastatic disease

What the study is looking for

  • ✓Participants are eligible to be included in the study only if all of the following criteria apply:
  • ✓Is 18 years of age or of the legal adult age per local standard at the time of signing the agreement to take part.
  • ✓Has confirmed by a biopsy HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a...
  • ✓Participants with unresectable or that has spread HER2 positive breast cancer who have progressed on, or are intolerant...
  • ✓Must have received at least 2 lines of HER2-directed therapy for their that has spread disease.
See the full 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.

Where Is This Study? (8 UK sites)

Royal United Hospital

Bath BA1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Beatson West Of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Leicester Royal Infirmary

Leicester LE2 7LX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Charring Cross Hospital

London W6 8RF, United Kingdom

Recruiting

The Christie - PPDS

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Churchill Hospital

Oxford OX3 7LJ, United Kingdom

Recruiting

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

How to Get in Touch

Clinical Trial Disclosure & Transparency

Sponsor contact

CONTACT

215-832-3750 ClinicalTrialDisclosure@JazzPharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02