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 must be postmenopausal, meaning no menstrual periods for 12 months without another medical explanation (a hormone blood test called FSH may be used to confirm this in some cases).
- A recent diagnosis (within the past 12 months) of a specific non-invasive breast condition called ER-positive DCIS, where breast-conserving surgery with clear margins and radiation therapy has already been completed (confirm with trial site for cases where radiation may have been omitted).
- A diagnosis within the past 3 years of certain high-risk breast tissue changes known as ADH, LCIS, or ALH.
- A calculated breast cancer risk of at least 3% over 5 years, or at least 5% over 10 years, based on one of two specific risk assessment tools (the Breast Cancer Surveillance Consortium calculator V3 or the Tyrer-Cuzick model V8).
- Confirmed carriers of an inherited gene change in either the CHEK2 or ATM gene, which are linked to a moderately increased cancer risk.
- Women who received radiation to the chest area before the age of 30.
- A general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG performance status 0 or 1).
- Able to swallow tablets or capsules by mouth.
- People who have had another cancer diagnosed 3 or more years ago (other than breast or endometrial cancer) may be eligible, provided that cancer or its treatment is unlikely to affect the safety or results of this trial.
- Able to understand the trial and willing to sign a written consent form.
- A mammogram (breast X-ray) completed within the 6 months before signing the consent form.
- A DEXA scan (a bone density scan) completed within the 12 months before signing the consent form.
- A life expectancy of 10 years or more.
- Normal liver function and normal blood cell counts on recent tests.
- A negative gynaecological examination completed within 6 months before signing the 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.
- Women who are pre-menopausal or peri-menopausal (still having or recently having had periods).
- People with a history of deep vein thrombosis (a blood clot in a vein, often in the leg) or pulmonary embolism (a blood clot in the lungs).
- People with a history of endometrial cancer (cancer of the lining of the uterus/womb).
- People with certain eye conditions affecting the macula (the central part of the retina).
- People who are unable to follow the study procedures as required.
- People who have used anti-oestrogen medications within the 12 months before signing the consent form.
- People who have used hormone replacement therapy (HRT) within the 3 months before signing the consent form.
- People with severe bone thinning (osteoporosis with a T-score of −2.5 or lower at the spine or hip), or a recent spinal fracture within the past 6 months that has not been treated with zoledronic acid or denosumab.
- People currently taking any of the following medications: terbinafine, quinidine, cinacalcet, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort, warfarin, erythromycin, cyclosporin, nifedipine, or any coumarin-type blood-thinning medication.
- People with moderate or severe kidney problems.
- People with a known allergy or sensitivity to the study medications.
- Only women are being recruited for this trial; men are not eligible.
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
Principal Investigator: Judy Garber, MD. MPH, Dana-Farber Cancer Institute
Phone: 617-632-2282
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
Difference in Overall Domain Score Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Between the Two Arms at 12 Months
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.