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
- Adults aged 18 to 75 years old.
- People diagnosed with HER2-positive invasive breast cancer confirmed by laboratory testing, where HER2 is strongly positive on tissue staining (IHC 3+) and/or confirmed by a gene test called FISH.
- People whose breast cancer is either locally advanced and cannot be operated on, or has come back or spread to other parts of the body — and if it has come back locally, the treating doctor must have confirmed that surgery to fully remove it is not possible.
- People who have at least one tumour that can be measured using standard imaging guidelines (called RECIST 1.1).
- People with a general health and activity level rated 0 or 1 on a standard scale used by doctors (called the ECOG score), meaning they are fully active or have only minor limitations in physical activity.
- People who have not received any systemic anti-cancer treatment for their advanced or metastatic disease, except for first-line hormone therapy.
- People whose blood test results meet minimum levels for blood cells: neutrophils (a type of white blood cell) ≥1.5×10⁹/L, platelets ≥90×10⁹/L, and haemoglobin ≥90 g/L — without having had a blood transfusion or blood-boosting medications in the two weeks before testing.
- People whose liver and kidney function blood tests fall within acceptable ranges as defined by the trial (confirm with trial site for specific values, particularly if liver spread or Gilbert syndrome is present).
- People whose heart pumping function, measured by an ultrasound of the heart, shows the heart is pumping at 50% or above (called LVEF ≥50%).
- People whose heart rhythm test (ECG) shows a specific measurement called QTcF below 470 milliseconds.
- People whose expected survival is at least 3 months.
- People who are willing to take part voluntarily, sign a consent form, follow the trial requirements, and attend follow-up appointments.
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 with a known allergy to any of the ingredients in the trial medications.
- People the treating doctor considers unsuitable for chemotherapy.
- People who have used hormone therapy drugs within the 14 days before the baseline assessment.
- People whose only measurable areas of cancer are in the bones or skin.
- People who have had another cancer in the past 5 years, except for certain treated cancers such as cervical carcinoma in situ, or basal cell or squamous cell skin cancer that has been cured.
- People with significant nerve damage in their hands or feet rated grade 3 or higher on a standard medical scale (CTCAE 5.0) (confirm with trial site).
- People who have had major surgery or a serious physical injury within 4 weeks before joining the trial, or who are expected to need major surgery during the trial.
- People with serious heart conditions, including but not limited to: a history of heart failure or poor heart pumping function, certain types of abnormal heart rhythms, significant heart valve disease, a recent heart attack shown on ECG, or blood pressure that is not well controlled (above 150/100 mmHg).
- People who have difficulty swallowing, ongoing severe diarrhoea, or bowel obstruction, or other conditions that could affect how the trial medication is taken in or absorbed.
- People with a weakened immune system, including those with HIV infection, other immune deficiency conditions (inherited or acquired), or a history of organ transplantation.
- People who have taken part in another clinical drug trial within 4 weeks before screening.
- People with a build-up of fluid in body cavities (such as around the lungs or in the abdomen) that cannot be controlled by draining or other methods.
- Women who are pregnant or breastfeeding, or women of childbearing age who are unable to use effective contraception throughout the trial.
- People with a serious ongoing illness or other medical condition that would interfere with the planned treatment or make participation unsuitable, such as active hepatitis B or a lung infection requiring treatment.
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
Phone: +86 13973135318
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
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.