Phase 1 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
- The person must speak English.
- Signed informed consent must be provided by the participant and/or their legally authorised representative.
- For younger participants where relevant, agreement to take part will also be sought in line with the institution's guidelines.
- The person must agree to allow stored tissue from a previous tumour biopsy to be used; if that tissue is not available, exceptions may be considered with approval from the lead study doctor.
- The person must be 18 years of age or older.
- The person must have a laboratory-confirmed diagnosis of breast cancer that cannot be surgically removed or has spread to other parts of the body, and the cancer must be hormone receptor positive (meaning the tumour has significant levels of oestrogen and/or progesterone receptors) and HER2 negative (as defined by established oncology guidelines).
- The cancer must have continued to grow or spread during or after a previous hormonal treatment, either as a first-line treatment for advanced or metastatic breast cancer, or during or within two years of finishing a type of treatment called a CDK4/6 inhibitor given for early-stage breast cancer.
- The person must have a general health and activity level rated at 2 or below on a standard medical scale used to measure how much a person's illness affects their daily activities (confirm with trial site).
- The person must have at least one tumour area that can be safely reached with a needle biopsy through the skin.
- The person must be considered medically appropriate to undergo a biopsy procedure.
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 received certain treatments for metastatic breast cancer, including capecitabine, PI3K inhibitors, mTOR inhibitors, AKT inhibitors, SERDs, or HER2-targeted therapies including neratinib (confirm with trial site for exact drug names).
- People who have known, untreated, or active cancer spread to the brain or the lining of the brain or spinal cord that is considered unsuitable for the type of treatment approach used in this study; however, people who have received radiation or other localised treatment before starting the study's main treatment may still be considered.
- People who have a history of other cancers, except for adequately treated non-melanoma skin cancer, cervical cancer in situ that was treated with curative intent, or other solid cancers that no longer require active treatment.
- People whose life expectancy is estimated to be less than one year.
- People who are pregnant or breastfeeding.
- People who have any other health condition that the study doctor believes would make participation unsafe or unsuitable.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Turnaround time (feasibility)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.