Phase 2 Breast Cancer Trial, 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
- Adults who are male or postmenopausal female, aged 18 or older, who are able to give written consent to participate.
- People with a confirmed diagnosis of a type of breast cancer that is hormone receptor-positive (HR+) and HER2-negative, confirmed by a laboratory test.
- People whose cancer has a specific genetic change in the PI3K pathway — either a PIK3CA mutation, PTEN loss, or AKT1 mutation — confirmed by an FDA-approved test.
- People whose breast cancer is locally advanced or has spread (metastatic) and cannot be cured, and who have experienced disease progression after receiving both hormone therapy and a CDK 4/6 inhibitor (either in early-stage or metastatic treatment), or who were newly diagnosed with advanced breast cancer and experienced disease progression during or after receiving hormone therapy plus a CDK 4/6 inhibitor.
- People whose cancer has at least one area that can be measured on imaging scans, according to standard criteria (certain bone lesions may also qualify; confirm with trial site).
- People who are generally well enough to carry out light daily activities, with little to no limitation, as assessed by a standard performance scale (ECOG score of 0 or 1).
- People with blood sugar levels within certain ranges at the start of the trial — specific ranges differ depending on which study drug is being considered (confirm with trial site).
- People with a body mass index (BMI) of 20 or above.
- People who meet the definition of postmenopausal, which may include not having had a period for more than 2 years, having had both ovaries removed, having hormone levels in the postmenopausal range confirmed by blood tests, or being on ovarian function suppression treatment.
- People who have previously received fulvestrant treatment may still be eligible, as long as their cancer did not progress on fulvestrant alone.
- People who have previously received certain targeted therapies (mTOR, PI3K, or AKT inhibitors) may still be eligible depending on which study drug they would be assigned (confirm with trial site).
- People who have had no more than one prior chemotherapy treatment for their metastatic breast cancer.
- People who are able and willing to attend clinic visits without eating for more than 8 hours beforehand on specified days.
- People whose blood test results for bone marrow and organ function (including blood counts, liver enzymes, kidney function, and other markers) fall within the ranges required by the trial (confirm with trial site for specific values).
- People who are able to swallow oral medications.
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 inflammatory breast cancer at the time of screening.
- People who have a known primary brain tumour, active cancer that has spread to the brain, active central nervous system disease, or who are considered neurologically unstable; also people who have received steroid medications within 4 weeks before joining, or whose brain scans have changed in the past two months.
- People who have a known allergy or sensitivity to any of the study drugs (evexomostat, fulvestrant, alpelisib, or capivasertib) or their ingredients.
- People with type 1 diabetes, or type 2 diabetes that is not well controlled (based on specific blood sugar thresholds depending on the assigned study drug), or who have taken insulin in the 4 weeks before starting the trial.
- People who have had major surgery within the past 30 days, minor surgery within the past 14 days, or who have not fully recovered from a previous surgery.
- People who still have significant side effects from previous cancer treatments that have not resolved to acceptable levels (except for hair loss).
- People with a certain level of liver disease severity, as measured by a liver scoring system called Child-Pugh (scores B or C are not eligible).
- People with HIV infection that is not well controlled.
- People who have received radiotherapy within the past 4 weeks (or limited palliative radiation within the past 2 weeks) and have not recovered sufficiently from its side effects, or where a large portion of their bone marrow was included in the radiation field.
- People who currently have another type of cancer, or have had another cancer within the past 2 years — except for certain treated skin cancers or cervical cancer that was fully removed.
- People with digestive system conditions that may significantly affect how study drugs are absorbed, such as severe nausea, uncontrolled diarrhoea, malabsorption, or a history of gastric bypass or bowel removal surgery (as assessed by the treating doctor).
- People who currently have, or have had unresolved, inflammation of the lungs (pneumonitis or interstitial lung disease).
- People who are currently taking certain medications that cannot be stopped at least 7 days before starting the trial — including strong CYP3A4 inducers, BCRP inhibitors, or sulfonylurea-type diabetes medications (confirm with trial site for specific drug names).
- People who have had acute pancreatitis (sudden pancreas inflammation) within the past year, or who have a history of chronic pancreatitis.
- People with unresolved osteonecrosis of the jaw (a bone condition affecting the jaw) — this applies only to those being considered for the drug alpelisib (confirm with trial site).
- People who have had a history of severe skin reactions, such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, or a severe drug reaction involving the immune system (DRESS).
- People who are currently taking, or have taken, systemic corticosteroid (steroid) medications within the 2 weeks before starting the trial and have not fully recovered from their effects — certain limited uses of steroids (such as topical creams, eye drops, or inhaled sprays) are permitted.
- People who are currently breastfeeding or who are pregnant.
- People who have taken part in another clinical trial within 21 days before starting this trial, or within 5 half-lives of the experimental drug used in that trial, whichever is longer.
- People with other serious or uncontrolled medical conditions that the treating doctor considers would make participation unsafe, such as active hepatitis, severe liver disease, or uncontrolled heart disease.
- People who are unable to understand or follow the trial instructions, including the fasting requirements.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Medical Team, SynDevRx, Inc.
Phone: +1-615-975-7776
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
Where this trial is recruiting
Primary endpoints
Incidence of Adverse Events; Hyperglycemic Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.