Phase 3 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 with breast cancer that cannot be removed by surgery and has either spread to nearby areas or to other parts of the body (metastatic).
- People with a confirmed diagnosis of breast cancer that is hormone receptor (HR)-positive and HER2-negative.
- Women who are postmenopausal.
- People who have not previously received any systemic (whole-body) cancer treatment for their breast cancer that has returned or spread, though prior chemotherapy given before or after early-stage breast cancer surgery is allowed, provided the cancer has since progressed.
- People who have either cancer that can be measured on scans, or cancer that has spread only to the bones in a way that cannot be measured on scans.
- People with a general health and activity level rated 0–2 on a standard medical scale (meaning able to carry out at least some daily activities, even if limited) (confirm with trial site).
- People whose kidneys, liver, blood cells, and other organs are functioning at an adequate level.
- People whose side effects from any previous cancer treatment or surgery have mostly resolved, with only mild effects remaining (confirm with trial site).
- People with a body mass index (BMI) between 19 and 39.
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 whose cancer has spread extensively to internal organs and is causing serious symptoms that could become life-threatening in the near future.
- People with inflammatory breast cancer.
- People with cancer that has spread to the brain or spinal cord and is not well controlled or is causing symptoms.
- People who have or have had another cancer within the past 3 years, with some exceptions such as certain treated skin cancers or cervical cancer that was fully removed.
- People with active heart disease or a documented history of heart problems.
- People with high blood pressure that is not well controlled.
- People with a history of bone fractures caused by fragility (such as fractures from a minor fall or with no injury, in areas such as the spine, hip, pelvis, or wrist).
- People with medical conditions known to cause low bone density.
- People with a history of inflammation of the lungs (ILD or pneumonitis).
- People with serious medical or mental health conditions, including recent or active thoughts of self-harm or suicide, or significant abnormalities in blood tests or heart tracings, that in the trial doctor's judgement would make participation unsafe or affect results.
- People with a detectable active viral infection such as hepatitis B, hepatitis C, or HIV. Note: People who have been successfully treated for these infections and have no detectable virus may still be considered eligible (confirm with trial site).
- People who have had major surgery, chemotherapy, radiation therapy, or other cancer treatments within 14 days before joining the trial; people who previously received radiation to more than 25% of their bone marrow are not eligible regardless of when that occurred.
- People whose bone-strengthening medication (bisphosphonates or RANKL inhibitors) was started or had its dose changed within 14 days before joining the trial — the dose must have been stable for at least 14 days prior.
- People who have used hormonal medications or other medications, herbal products, or supplements known to affect certain hormone levels (including hormone replacement therapy, contraceptive pills, androgens, or treatments for hot flushes given by any route including topical or vaginal) within 3 months before joining the trial, with limited exceptions (confirm with trial site).
- People who have used certain medications that interact with specific liver enzymes (CYP3A or CYP2A6), including St. John's Wort and grapefruit or grapefruit juice, within approximately 3 days to 5 half-lives before joining the trial (confirm with trial site).
- People currently receiving any other cancer treatment at the same time as 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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +34 913756230
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
Progression Free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.