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 person has breast cancer that has been confirmed by a pathology test, cannot be removed by surgery, or has spread to other parts of the body.
- The cancer has a low level of a protein called HER2, measured at specific levels (IHC 2+/ISH- or IHC 1+) on testing.
- The cancer is hormone receptor-positive (meaning it is fuelled by hormones such as oestrogen or progesterone).
- The cancer has continued to grow or spread despite hormone-based treatments, and hormone-based treatments are no longer expected to help.
- The person has received either no chemotherapy, or one round of chemotherapy, for this advanced or returning cancer.
- The cancer has never previously tested as high-HER2 (IHC 3+ or ISH+) on any prior pathology test, according to established clinical guidelines.
- The cancer tests positive for a marker called PD-L1, with a score of 1 or higher (CPS ≥ 1).
- Scans or imaging have confirmed the cancer has grown or spread during or after the most recent treatment.
- Stored tumour tissue samples are available, or the person is willing to have a fresh tissue sample taken before the trial begins, for HER2 and treatment-response testing.
- There is at least one tumour that can be measured on scans, according to standard research measurement criteria.
- Heart, bone marrow, kidney, liver, and blood-clotting functions all meet the levels required by the trial protocol.
- People of reproductive potential (male or female) must agree to use contraception as directed by the trial, and to avoid storing eggs or sperm for at least 4.5 months after treatment ends (or longer, as required by local guidelines).
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.
- The person has a known allergy to any monoclonal antibody or to tucidinostat, or has previously had a severe allergic reaction (grade 3 or higher) to these types of medicines.
- The person has previously been treated with a type of drug called a histone deacetylase inhibitor, an immune checkpoint inhibitor, or a medicine that targets blood vessel growth (angiogenesis inhibitor).
- The person has an active, known, or suspected autoimmune disease, or a history of autoimmune disease.
- The person has active cancer that has spread to the brain or the lining around the brain or spinal cord.
- The person has received a live vaccine within 4 weeks before the first dose of the trial treatment.
- The person has had major surgery, a serious injury, a significant fracture, or an ulcer within 4 weeks before the first dose of the trial treatment.
- The person is currently pregnant or breastfeeding.
- The person has serious uncontrolled health conditions, including active infection, unstable chest pain (angina), chest pain that occurred within the past 3 months, moderate-to-severe heart failure, a heart attack within the past 6 months, serious irregular heartbeat, or significant liver, kidney, or metabolic disease.
- The person is currently participating in another clinical trial, or has done so within 4 weeks before enrolling in this trial.
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
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(PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.