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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (8 UK sites)
Royal United Hospital
Bath BA1 3NG, United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Leicester Royal Infirmary
Leicester LE2 7LX, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Guy's Hospital
London SE1 9RT, United Kingdom
Charring Cross Hospital
London W6 8RF, United Kingdom
The Christie - PPDS
Manchester M20 4BX, United Kingdom
Churchill Hospital
Oxford OX3 7LJ, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Clinical Trial Disclosure & Transparency
Sponsor contactCONTACT
