Printed from Voxsanity (voxsanity.com.au) — NCT07494448 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07494448
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are able to understand the purpose of the study and have signed a written consent form before any study procedures begin.
- People who are 18 years of age or older at the time of signing the consent form.
- People with a general health status rated as 0 or 1 on the ECOG scale, meaning they are fully active or have minor restrictions on physically demanding activity (confirm with trial site).
- People with a life expectancy of at least 12 weeks at the time of screening.
- People whose cancer has spread to other parts of the body or cannot be surgically removed with the goal of cure, as confirmed by CT scan or MRI.
- People who have been locally confirmed to have HER2-positive breast cancer, based on specific laboratory testing of a recent tumour biopsy, meeting defined testing standards (confirm with trial site).
- People whose disease can be measured or assessed using standard imaging criteria known as RECIST v1.1 (confirm with trial site).
- People whose cancer has gotten worse after at least one, but no more than three, prior treatments targeting HER2 for advanced disease.
- People who are able to provide their most recently available tumour tissue sample stored in a specific medical format (FFPE block) — if no stored sample is available, eligibility will need to be discussed with the trial's Medical Monitor.
- People who are able to provide blood samples at the required time points during the study.
- People whose bone marrow, blood clotting, liver, and kidney function meet specific minimum levels as measured by blood tests (confirm with trial site for exact values).
- People whose blood counts meet minimum thresholds for neutrophils, platelets, and haemoglobin — those who have received blood transfusions must have had the transfusion at least 14 days before starting treatment; people with chronic anaemia supported by occasional red blood cell transfusions (other than autoimmune haemolytic anaemia) may be eligible.
- People whose blood clotting measures (INR and aPTT) are within an acceptable range, unless they are on medications known to affect these values — note that warfarin and similar blood-thinning medications are not permitted.
- People whose liver function blood test results (bilirubin, AST, and ALT) fall within acceptable ranges — slightly higher limits apply for people with a condition called Gilbert's disease or those with liver metastases (confirm with trial site).
- People whose kidney function, as measured by blood creatinine levels or a calculated kidney clearance rate, meets the minimum required level.
- Women who could become pregnant must have a negative blood pregnancy test within 14 days before the first dose of study treatment.
- Women who could become pregnant, and men whose partner could become pregnant, must agree to use two forms of birth control with a failure rate of less than 1% per year, starting at screening and continuing throughout the study and for 12 months after the last dose of study treatment.
- Women must agree not to donate eggs or breastfeed during the study and for 12 months after the last dose; men must agree not to donate or bank sperm during the same period.
- People who are able to attend treatment sessions and follow-up visits as required.
- People with brain metastases (cancer that has spread to the brain) may be eligible if they meet specific additional conditions, including: brain metastases that have been radiographically stable for at least 4 weeks after treatment; untreated brain lesions that do not immediately require local treatment (larger untreated lesions require Medical Monitor approval); or brain metastases that have progressed after prior local brain treatment but do not immediately require retreatment.
- People with brain metastases must meet specific waiting periods after prior brain radiation treatment before joining — more than 7 days after certain types of focused radiation, and more than 24 days after whole-brain radiation; steroid use for brain metastasis symptoms must be at a low stable dose (confirm with trial site); and people on anti-seizure medication must have been on a stable dose for at least 14 days before the first study treatment dose.
- In the second phase of the trial, at least 50% of participants enrolled must have brain metastases.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who are currently participating in another clinical trial — whether interventional or observational — until the safety visit for this study is complete (participation in retrospective studies or data analysis only is permitted).
- People who have received any systemic cancer treatment (including hormonal therapy), radiation to areas other than the brain, or an experimental treatment within 3 weeks before the first dose of study treatment — a shorter waiting period may apply for palliative radiation on a case-by-case basis (confirm with trial site).
- People who have previously been treated with both capecitabine and eribulin.
- People with known or suspected spread of cancer to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
- People with advanced cancer that has spread to internal organs in a way that poses a risk of life-threatening complications in the short term, such as large uncontrolled fluid build-up in the chest, heart sac, or abdomen, or cancer blocking the lung's lymph vessels.
- People who have received a live vaccine within 4 weeks before joining the study.
- People who have previously had a bone marrow transplant, stem cell transplant, or solid organ transplant from another person.
- People who have not completed required waiting periods after prior cancer treatments before starting the study — the waiting period is up to 3 weeks for chemotherapy or monoclonal antibody treatments (including antibody-drug conjugates), up to 2 weeks or 5 half-lives (whichever is shorter) for certain targeted therapy pills, and no waiting period is required for hormone therapy or certain hormone-regulating injections (confirm with trial site).
- People who require ongoing use of any medications listed as prohibited in the study protocol (confirm with trial site).
- People with a known allergy or serious hypersensitivity reaction to any of the study drugs or their ingredients, including severe reactions to monoclonal antibodies or to substances in a drug called zanidatamab.
- People who still have significant side effects from previous cancer treatments that have not improved to a mild level (Grade 1 or lower), with the exception of hair loss or other side effects considered low-risk by the treating doctor.
- People who have or have had another cancer within 5 years of joining the study — exceptions include certain skin cancers or pre-cancerous cervical conditions that have already been treated with the goal of cure; other low-recurrence-risk cancers require discussion with the study's Medical Monitor.
- People who have had a major surgical procedure or serious injury within 4 weeks before the first dose, or who are expected to need major surgery during the study.
- People with significant heart conditions, including: abnormal heart rhythms requiring treatment; uncontrolled high blood pressure (above defined thresholds even on blood pressure medication); a history of symptomatic heart failure of a certain severity; significant abnormality of a heart electrical measurement called QTc on a screening heart trace (ECG); conditions that could increase the risk of a dangerous heart rhythm problem (such as inherited or acquired long QT syndrome, a family history of sudden death, a history of drug-induced QT prolongation, or current use of medications known to carry this risk); a heart attack or unstable chest pain within 6 months before the first dose; or a weakened pumping function of the heart (left ventricular ejection fraction below 50%) as measured by a heart scan within 4 weeks before the first dose.
- People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, currently active lung inflammation, or suspected lung inflammation that cannot be ruled out by imaging at screening.
- People with serious breathing difficulties caused by other lung conditions, including but not limited to blood clots in the lungs within 3 months of enrolment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restricted lung function, fluid around the lungs, lung scarring after COVID-19, certain autoimmune or inflammatory conditions affecting the lungs, or prior surgical removal of a lung.
- People with moderate or severe nerve damage in their hands or feet (peripheral neuropathy Grade 2 or higher).
- People with a known history of significant bleeding, blood clots, bowel blockage, or a hole in the gastrointestinal tract within 3 months before joining the study.
- People with an active hepatitis B or hepatitis C infection — people with a past resolved hepatitis B infection meeting specific testing criteria may be eligible; people who test positive for hepatitis C antibody may be eligible only if further testing shows no active virus present.
- People with a known HIV infection — however, people living with HIV who are on stable antiretroviral therapy (ART) with well-controlled HIV may be eligible if they meet specific additional criteria, including adequate immune cell counts, confirmed viral suppression for at least 12 weeks before screening, a stable ART regimen for at least 4 weeks before joining, and an ART regimen that does not interfere with the study treatments (confirm with trial site).
- People with any other uncontrolled active infection at the time of enrolment.
- People with a known inherited or acquired deficiency of an enzyme called DPD, which must be checked before treatment with capecitabine according to current guidelines.
- People who are unable to swallow pills or who have significant digestive tract problems that would prevent proper absorption of oral medications.
- People with any other serious medical condition or abnormal laboratory results that, in the opinion of the treating doctor, would make participation unsafe.
- In the second phase of the trial only: people who have previously been treated with HER2 tyrosine kinase inhibitor (TKI) medications.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: + 34 932 214 135
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
MedSIR
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
31 December 2027
Primary endpoints
To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and capecitabine in participants with HER2-positive ABC (Cohort A).; To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and eribulin in participants with HER2-positive ABC (Cohort B).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.