Breast Cancer Trial, Not Yet Recruiting
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 voluntarily sign a consent form agreeing to take part in the study.
- Women aged 18 or older at the time of signing the consent form.
- People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning able to carry out at least some daily activities independently).
- People with breast cancer that has spread to other parts of the body (metastatic), confirmed by laboratory testing to be HER2-positive (a specific protein found on some cancer cells).
- People who have brain metastases (cancer that has spread to the brain) confirmed by MRI or enhanced CT scan, with at least one measurable affected area in the brain according to standard measurement guidelines.
- People with an expected survival of at least 3 months.
- People who fall into one of two groups: those newly diagnosed with brain metastases (Cohort A), or those whose brain metastases have progressed after receiving whole-brain radiotherapy or a type of targeted radiation treatment called stereotactic radiosurgery (Cohort B).
- People whose heart is pumping at least 50% of its capacity, as measured by a standard heart function test.
- People whose heart's electrical activity, measured by a 12-lead ECG, shows a corrected QT interval below 470ms for women (confirm with trial site for male-specific threshold if relevant).
- People whose blood test results meet minimum levels for infection-fighting cells, platelets, red blood cells, and overall white blood cells (confirm specific values with trial site).
- People whose liver function blood test results fall within acceptable ranges, with slightly higher limits allowed if the cancer has spread to the liver (confirm specific values with trial site).
- People whose kidney function blood test results fall within acceptable ranges (confirm specific values with trial site).
- Women who are either unable to become pregnant, or if able to become pregnant: have a negative blood pregnancy test within 7 days before the first dose, are not breastfeeding, and are using effective contraception during the study and for 6 months after the last dose.
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 have previously been treated with a type of cancer drug called an anti-HER2 ADC (antibody-drug conjugate).
- People who have previously received both pyrotinib and neratinib (two specific targeted cancer drugs) one after the other.
- People with extensive cancer spread to the lining of the brain and spinal cord (leptomeningeal metastases) that has responded poorly to steroid treatment.
- People with significant build-up of fluid in body cavities, such as around the lungs or in the abdomen, that cannot be managed by draining or other treatments.
- People who have received chemotherapy, major surgery, or targeted cancer therapy within 2 weeks before joining; hormone therapy within 1 week before joining; or certain specific chemotherapy drugs (nitrosoureas or mitomycin) within 6 weeks before joining.
- People currently receiving any other cancer treatment at the same time.
- People who have had, or currently have, another cancer diagnosis within the past 5 years — except for certain early-stage or cured cancers including cervical carcinoma in situ, non-melanoma skin cancer, and certain early-stage bladder cancers.
- People who had major surgery or a serious injury, have wounds or fractures that have not healed, or are expected to need major surgery during the study, within the 4 weeks before joining.
- People who have had a heart attack in the past 6 months; have poorly controlled moderate-to-severe heart failure; have severe uncontrolled abnormal heart rhythms; or whose heart pumping function dropped below 50% during or after previous treatment with the drug trastuzumab.
- People with a known allergy to any of the drugs or ingredients used in this trial.
- People with a known history of severe allergic reactions to any of the study drugs.
- People considered unsuitable for the trial for other reasons, as determined by the study investigators.
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.
Contact this trial
Principal Investigator: Yan Xue, Xi'an International Medical Center Hospital
Phone: 0086-13992830596
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Progression-free survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.