Phase 4 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 who are premenopausal or postmenopausal — postmenopausal status is defined as having had both ovaries removed, being aged 60 or older, or being under 60 with periods stopped naturally for at least 12 consecutive months and hormone levels confirmed at postmenopausal levels.
- People diagnosed with invasive breast cancer that tests positive for estrogen receptors (more than 10%) and negative for HER2, regardless of progesterone receptor results, confirmed by specific laboratory testing methods.
- People with stage II or stage III breast cancer at initial diagnosis, as classified under the AJCC 8th edition staging system.
- People with no known severe allergic reactions to darcilil, similar compounds, or the inactive ingredients used in darcilil.
- People with a physical performance status rated as ECOG 0 or 1, meaning they are fully active or able to carry out light activity (confirm with trial site).
- People who are able to swallow oral (by mouth) medications.
- People whose bone marrow is functioning at required levels — including adequate white blood cell counts, platelet counts, and haemoglobin levels — without needing recent corrective treatments.
- People whose liver and kidney function test results fall within the required ranges as measured by specific blood tests.
- People whose heart electrical activity, measured by a 12-lead ECG, shows a QT interval of 480 milliseconds or less.
- People who are willing and able to undergo all needle biopsies required by the study.
- People who voluntarily agree to take part, sign a consent form, are willing to follow the study requirements, and are able to 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 form of cancer treatment, including chemotherapy, radiation therapy, targeted therapy, or hormone therapy.
- People who are currently receiving any other cancer treatment outside of what is set out in this trial's protocol.
- People with cancer in both breasts, inflammatory breast cancer, or locally advanced breast cancer that cannot be surgically removed (confirm with trial site for exact definition of "ocessive").
- People with stage IV (metastatic) breast cancer.
- People who have been diagnosed with another cancer in the past 5 years.
- People with serious problems affecting the heart, liver, kidneys, or other vital organs.
- People who are unable to swallow, have ongoing diarrhoea, or have a bowel obstruction, or other conditions that would interfere with taking or absorbing the study medication.
- People with a known allergy to any ingredient in the study medication.
- People with a history of immune system deficiency, including HIV, Hepatitis C (HCV), active Hepatitis B, other immune deficiency conditions, or a history of organ transplant.
- Women who are pregnant or breastfeeding, women who test positive for pregnancy at the start of the study, or women of childbearing age who are unwilling to use effective contraception throughout the trial.
- People with other ongoing medical conditions — such as severe high blood pressure, severe diabetes, or active infection — that the study doctor believes could seriously affect the person's safety or ability to complete the study.
- People with a known history of neurological or psychiatric conditions, including epilepsy or dementia, or anyone the study 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.
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
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.