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
- People who are over 18 years old, of any gender.
- People whose breast cancer has been confirmed by laboratory testing to be hormone receptor (HR) positive and HER2 negative, and has spread or returned (advanced stage).
- For the dose-finding stage of the trial: people whose doctor considers them currently suitable to take the study drug, with no restrictions on previous treatments. For the later expansion stage: people whose cancer came back or got worse during hormone therapy given before or after surgery, or within 12 months of finishing it; who have received no more than one round of chemotherapy since the cancer spread; and who have not previously received a type of treatment called a CDK4/6 inhibitor for their advanced or spreading cancer.
- People who have at least one area of cancer that can be measured using standard imaging criteria (known as RECIST v1.1); people with cancer that has spread only to the bone may still be eligible for the dose-finding stage (confirm with trial site).
- People who are reasonably active and able to care for themselves, as measured by a standard medical scoring system called the ECOG performance status score of 0 or 1.
- People whose expected survival is more than 6 months.
- People whose major organs (such as liver, kidneys, and bone marrow) are functioning within the levels required by the trial, as tested within 7 days before starting treatment.
- People who are willing to take part, understand what the study involves, and are able to sign a consent form.
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 been diagnosed with HER2-positive breast cancer through pathology testing.
- People whose doctor considers them unsuitable for hormone-based therapy — for example, those with a serious, immediately life-threatening condition such as uncontrolled large fluid build-ups around the lungs, heart, or abdomen; cancer spreading through the lung's lymph vessels; or the liver being more than 50% affected by cancer.
- People who have previously been treated with a medicine called fulvestrant, or with drugs that target a group of cell-signalling pathways known as PI3K, AKT, or mTOR.
- People with uncontrolled fluid build-up in body cavities (such as around the heart, lungs, or in the abdomen) that requires repeated drainage or other ongoing treatment, and whom the investigator considers ineligible.
- People with a history of serious lung conditions such as interstitial lung disease, severe pneumonia, pulmonary hypertension, or radiation-related lung inflammation that required steroid treatment.
- People with ongoing bowel or digestive conditions that mainly cause diarrhoea — such as Crohn's disease, ulcerative colitis, or poor nutrient absorption — or diarrhoea of at least a mild level, bowel blockage, or other digestive problems considered clinically significant by the investigator.
- People with known blood-clotting disorders or a tendency to bleed, or who need to take blood-thinning medications that may interfere with injections required as part of the treatment.
- People with a known allergy or intolerance to any ingredient in the study drug(s) or related medications used in the trial.
- People with a history of autoimmune diseases (except tuberous sclerosis), immune system deficiency conditions (including a positive HIV test), other inherited or acquired immune disorders, or a history of organ transplantation.
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: 86-0311-69085587
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
The occurrence and frequency of adverse events (AE); dose-limiting toxicities (DLT); The recommended phase 3 dose; The occurrence and frequency of serious adverse events (SAE); Overall reponse rate（ORR）
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.