Phase 4 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 aged 18 years or older.
- Women who are premenopausal or perimenopausal must have a negative pregnancy test and agree to use reliable contraception throughout the treatment period.
- People with a laboratory-confirmed diagnosis of HER2-positive invasive breast cancer (based on specific test results known as IHC 3+, or IHC 2+ with a positive FISH test).
- People who have completed a standard course of pre-surgery chemotherapy and targeted therapy (a regimen called TCbHP, which includes taxane, carboplatin, trastuzumab, and pertuzumab), where imaging scans showed the cancer did not fully disappear (did not achieve a complete response).
- People who agree to have a core needle biopsy (a procedure where a small tissue sample is taken from the tumour).
- People who are fully active or have only mild restrictions in physical activity, as measured by a standard medical scale called the ECOG performance status (score of 0 or 1).
- People whose blood counts and organ function (including the liver and kidneys) meet specific healthy ranges as determined by blood tests (confirm with trial site for exact values).
- People whose heart is functioning well, with no signs of reduced blood flow to the heart on an ECG, a normal heart function classification (NYHA Class I), a heart pumping strength of 55% or above on an echocardiogram (heart ultrasound), and normal levels of certain heart-related markers in the blood.
- People who have read and signed an informed consent form agreeing to take part in the trial.
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 male breast cancer or inflammatory breast cancer.
- People whose breast cancer has spread to other parts of the body (Stage IV, or metastatic breast cancer).
- People who have, or have had within the past 5 years, another type of cancer — except for certain skin cancers (basal cell or squamous cell) that have been fully treated, or cervical carcinoma in situ.
- People who are currently receiving other cancer treatments or taking part in another clinical trial.
- People with a serious non-cancer illness that could affect their ability to follow the trial requirements or put them at risk.
- People who have had major surgery within 4 weeks before the trial starts, or who are expected to need major surgery during the trial.
- People who have had an allergic reaction to, or a medical reason to avoid, any ingredient in the study medication.
- People with dementia, a significant mental health condition, or a psychiatric illness that would prevent them from fully understanding the informed consent process.
- People whom the trial doctor considers unsuitable for the trial for any other reason.
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: 86-25-83714511
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
Primary endpoints
Total Pathological Complete Response (tpCR)
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.