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
- People who are willing to take part voluntarily, understand what the trial involves, and are willing to sign a consent form.
- People who are 18 years of age or older.
- Postmenopausal people with breast cancer that is hormone receptor (HR) positive and HER2 negative, where the cancer has spread locally or to other parts of the body, and who are currently receiving or have previously received hormone-based treatment.
- People whose menopause is caused by a GnRH agonist medication must have a negative blood pregnancy test during the screening period.
- People whose menopause is caused by a GnRH agonist medication must agree to use effective contraception from the time of joining the trial until at least 2 years after the last dose of study treatment (note: estrogen-based hormonal contraception, including hormonal intrauterine devices, is not allowed for breast cancer patients; progestin-based hormonal contraception has unclear effectiveness; acceptable methods include complete abstinence if that is their normal lifestyle, a non-hormonal intrauterine device, bilateral tubal ligation, a partner who has had a confirmed vasectomy, or a dual barrier method such as a male condom combined with a cervical cap, diaphragm, or contraceptive sponge used with spermicide).
- People who have at least one measurable area of cancer that can be assessed on scans.
- People with an ECOG performance status score of 0 or 1 at screening, meaning they are either fully active or have some limits on strenuous activity but can carry out light work (confirm with trial site).
- People with a life expectancy of at least 12 weeks.
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 central nervous system (brain or spinal cord) cancer spread that is causing symptoms, or cancer that has spread to the lining around the brain or spinal cord.
- People who have had another type of cancer in the past, unless they were fully cured of certain skin cancers or early-stage cervical cancer, or unless there has been no sign of the other cancer for 2 or more years and it requires no treatment.
- People whose fluid build-up around the heart, lungs, or abdomen cannot be controlled even after medical treatment.
- People who have had a transplant of an organ, bone marrow, or stem cells from another person.
- People who have had an allergic reaction to fulvestrant in the past, or who are prone to serious allergic reactions such as severe swelling, hives, asthma, or rashes.
- People with serious heart or blood vessel conditions, including: severe heart failure (NYHA class III or IV, assessed in those with a known heart condition history); reduced heart pumping function below 50% (if that information is available); uncontrolled irregular heart rhythms; a corrected heart electrical interval (QTcF) above 480 milliseconds, or an inherited condition affecting heart rhythm; a heart attack, severe chest pain, heart failure, stroke, mini-stroke, serious blood clot in the lungs, or other significant clotting events within the 6 months before starting the trial drug; heart bypass surgery within 6 months before starting the trial drug; a clinically significant abnormally slow heart rate as assessed by the investigator; or any other significant heart or blood vessel condition the investigator considers makes participation unsuitable.
- People who have HIV infection or test positive for HIV antibodies during screening.
- People with active hepatitis B (confirmed by specific blood test levels) or active hepatitis C (confirmed by specific blood test levels); people with hepatitis B or C who do not agree to follow established antiviral treatment guidelines will not be enrolled.
- People who needed antibiotic treatment given through a drip (intravenously) for an active infection within 1 week before starting the trial drug.
- People with moderate or severe liver damage, defined as meeting specific liver function classification criteria (Child-Pugh B or C) (confirm with trial site).
- People whose blood test results at the start of the trial show that key organs are not functioning well enough, based on specific laboratory value thresholds for white blood cells, liver enzymes, bilirubin, haemoglobin, platelets, kidney function, or blood clotting (confirm specific thresholds with trial site); these tests must be done without receiving blood products or certain blood-boosting medications in the 7 days beforehand.
- People who received certain anti-cancer treatments too recently before starting the trial drug, including hormone therapy, targeted therapy, radiotherapy (other than palliative or non-target-area radiotherapy), chemotherapy, immunotherapy, cell therapy, monoclonal antibodies, certain traditional Chinese medicines with anti-cancer indications, immunosuppressive therapy, or other investigational drugs or devices — each with specific minimum time gaps that must have passed (confirm exact timeframes with trial site).
- People with bleeding disorders such as problems with blood clotting, or who need long-term anticoagulant (blood-thinning) medication, not including antiplatelet therapy or low-dose warfarin or low-molecular-weight heparin.
- People who have had a serious blood clot event requiring medical or surgical treatment.
- People with active autoimmune diseases that require ongoing treatment with immune-modifying medications, steroids, or immunosuppressive drugs (note: people with thyroid conditions are eligible; hormone replacement and certain symptomatic treatments such as thyroid hormone, insulin, or low-dose steroids for specific hormone deficiencies are permitted and are not considered systemic treatment).
- People who received systemic corticosteroid (steroid) medications within the 4 weeks before starting the trial drug, unless the dose was low (equivalent to 20 mg or less of prednisone per day).
- People who had major surgery within the 4 weeks before starting the trial drug, or who are expected to need major surgery during the trial.
- People who are currently pregnant or breastfeeding, or who expect to become pregnant at any point from screening through to 2 years after the last dose of study treatment.
- People who have not yet recovered from side effects of previous treatments (including prior immunotherapy) or from surgical complications to a mild level or better (CTCAE v6.0 grade 1 or lower), noting that stable ongoing side effects at grade 2 or below that are not expected to resolve on their own — such as nerve tingling or hair loss — may still be eligible (confirm with trial site).
- People who the investigator 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.
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
Phone: 86+18357916536
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
Objective Response Rate Evaluated by Blinded Independent Central Review
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.