Phase 3 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 willing to take part and sign a consent form agreeing to join the study.
- People aged 18 years or older.
- People who have breast cancer that has spread or cannot be removed by surgery, confirmed by laboratory testing of tissue or cells.
- People whose cancer has tested HER2-positive through a central laboratory, meaning the cancer cells show a high level of the HER2 protein or gene amplification.
- People who have already received at least two different treatment regimens for their advanced or metastatic breast cancer.
- People whose cancer has been confirmed by imaging scans to have grown or spread during or after their most recent treatment.
- People who have at least one measurable or assessable area of cancer that can be tracked at the start of the study.
- People who have a general health and activity level rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
- People whose organs such as the liver, kidneys, and bone marrow are functioning at an adequate level.
- People who are expected to live for at least 12 weeks.
- People of childbearing potential, both female and male, who agree to use reliable contraception throughout the entire study.
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.
- Women who are pregnant or currently breastfeeding.
- People who have had another type of cancer in the past three years.
- People who still have significant side effects from previous cancer treatments that have not returned to a mild or pre-treatment level.
- People who have active inflammatory bowel disease, long-term diarrhoea, short bowel syndrome, or other gut conditions or prior treatments that could affect how the body absorbs medication.
- People who received systemic anti-cancer treatment within 28 days before being assigned to a study group, or certain approved traditional Chinese medicine cancer treatments or palliative radiotherapy within 2 weeks before being assigned.
- People who had major surgery (not including needle biopsies) within 28 days before being assigned to a study group.
- People who have already received the maximum lifetime allowable dose of a class of chemotherapy drugs called anthracyclines.
- People who have untreated or unstable cancer that has spread to the brain, spinal cord, or the membranes surrounding the brain and spinal cord.
- People who have a history of severely reduced heart pumping function (below 40%) or symptomatic heart failure.
- People with serious or uncontrolled heart or cardiovascular disease.
- People who have a history of lung inflammation (not caused by infection) that required treatment with steroid medication.
- People who currently have an eye or corneal condition requiring medication or surgery.
- People who have significant nerve damage in their hands or feet rated as grade 3 or higher on a standard medical scale (confirm with trial site).
- People who had an active infection requiring intravenous antibiotics, antiviral, or antifungal treatment within 2 weeks before being assigned to a study group.
- People with active hepatitis B or hepatitis C.
- People with a history of immune system deficiency conditions, including those who are HIV positive.
- People who have a known allergy or medical reason preventing them from taking the study drugs or their ingredients.
- People who are currently taking certain strong medications that significantly affect how a liver enzyme called CYP3A processes drugs (confirm with trial site).
- People with any other circumstances that could interfere with taking part in the study or mean the study may not be in their best interest.
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.
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: 86-0311-69085587
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.
Primary endpoints
Progression-free survival (PFS) by BIRC
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.