Phase 2 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 cancer must be stage II or III at the time of first diagnosis, based on the AJCC 8th edition staging system.
- Patients must be female and between 18 and 75 years of age (inclusive).
- The cancer must have been confirmed by laboratory testing to be HR+/HER2+, meaning the estrogen receptor (ER) is positive in more than 10% of cells, or the progesterone receptor (PR) is positive in more than 10% of cells, AND the HER2 protein is positive (confirmed by specific laboratory tests).
- Patients must have a performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity.
- There must be at least one tumour that can be measured using standard imaging criteria (RECIST 1.1).
- Blood, liver, kidney, and heart function must all meet specific minimum levels as measured by laboratory tests and a heart ultrasound (confirm with trial site for exact values).
- Patients must be willing to take part voluntarily, sign a consent form, follow the study 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 who have previously received any anti-cancer treatment, such as chemotherapy, radiation, targeted therapy, or hormone therapy.
- People who are currently receiving any other anti-cancer treatment.
- People who have had another type of cancer within the past 5 years, except for certain treated skin cancers, cervical carcinoma in situ that has been cured, or minimally invasive thyroid cancer that was fully removed by surgery.
- People who have severe problems with important organs such as the heart, liver, or kidneys.
- People who have difficulty swallowing, ongoing diarrhoea, or a blocked bowel, or other conditions that may affect how the study drug is taken or absorbed.
- People who have taken part in another clinical drug trial and received the experimental drug within the 4 weeks before enrolling.
- People who have a history of immune system diseases, including a positive HIV test, hepatitis C (HCV), active viral hepatitis, other immune deficiency conditions, or a history of organ transplant.
- People who have a known allergy to any ingredient in the study drug.
- People who have any significant heart condition, including arrhythmia requiring medication, a previous heart attack, heart failure, or any other heart condition the trial doctor considers unsuitable.
- Women who are pregnant or breastfeeding, or women who are able to become pregnant and have a positive pregnancy test at the start of the trial.
- People who have serious other health conditions that the trial doctor believes could put them at risk or prevent them from completing the study, such as uncontrolled high blood pressure, severe diabetes, or an active infection.
- People who have a known neurological or mental health condition, including epilepsy or dementia.
- People whom the trial doctor considers unsuitable 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: 13095520028
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
tpCR rate，total physiological complex response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.