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
- Women aged between 18 and 75 years.
- People who have been diagnosed with invasive breast cancer in one breast only, confirmed by a tissue biopsy.
- People whose cancer was found to be early stage (Stage I) after surgery, meaning the tumour was no larger than 2 cm and had not spread to the lymph nodes.
- People whose cancer tests show that at least 50% of the cancer cells respond to the hormone oestrogen (ER-positive).
- People whose cancer tests show a high level of a protein called HER2, either confirmed directly by tissue staining or confirmed through a specialised gene test (FISH) when the initial staining result was borderline.
- People whose tumour is graded as low or moderate (Grade 1 or 2), or selected higher-grade (Grade 3) tumours that also show a specific cancer subtype pattern on molecular testing, or a tumour size of 1 cm or smaller (confirm with trial site).
- People whose blood and organ function results meet the required levels, including healthy blood counts, liver function, kidney function, and a heart pumping function (LVEF) above 50%.
- People who are willing to take part, sign a consent form, and attend follow-up appointments as required.
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 whose tumour was larger than 2 cm or whose cancer had spread to the lymph nodes under the arm.
- People whose cancer tests show that HER2 levels are low or negative, or where a borderline HER2 result was not confirmed by the specialised gene test (FISH).
- People who received any treatment before surgery, such as chemotherapy, targeted therapy, radiation, or hormone therapy.
- People with a history of another cancer, except for certain skin cancers (basal cell carcinoma) or early cervical cell changes (cervical carcinoma in situ) that have been fully treated and cured.
- People whose breast cancer has spread to other parts of the body (Stage 4).
- People who are pregnant or breastfeeding, or people of childbearing potential who are unable to use effective contraception during the trial.
- People who are currently taking part in another clinical trial.
- People with serious heart, lung, liver, or kidney problems, including a heart pumping function (LVEF) below 50%, or a significant heart or stroke event within the past 6 months, or poorly controlled diabetes or high blood pressure.
- People with an active, serious, or uncontrolled infection.
- People with a history of substance dependency involving psychotropic drugs, or a documented psychiatric condition that may affect the ability to follow the trial requirements.
- People considered unsuitable for the trial by the lead doctor or study physician.
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.
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Trial details
Primary endpoints
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Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.