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 have been confirmed by tissue testing to have hormone receptor (HR)-positive, HER2-negative breast cancer.
- People whose cancer is at clinical stage II or III (not spread to distant parts of the body).
- Women who are post-menopausal, or men with breast cancer.
- People whose cancer treatment plan includes pre-surgery (neoadjuvant) treatment followed by surgery.
- People who are able to have an MRI scan (no medical reasons preventing it).
- People who are able to understand and follow the instructions given during the trial.
- People who are willing and able to sign and date a written consent form agreeing to take part.
- People who are at least 50 years old.
- People whose tumour can be reached for a biopsy and for surgery.
- People whose bone marrow is working well enough at screening and confirmed again at the baseline visit, including having sufficient levels of white blood cells, neutrophils, platelets, and haemoglobin, and a normal blood clotting measure (confirm specific values with trial site).
- People whose liver is functioning adequately at screening and confirmed at the baseline visit, based on specific blood test results for liver enzymes and bilirubin (confirm specific values with trial site).
- People whose kidneys are functioning adequately at screening and confirmed at the baseline visit, based on a kidney function calculation (eGFR) of at least 30 mL/min.
- People with a general health and activity level rated at 2 or below on a standard scale used by doctors (ECOG performance status).
- People expected to live for at least 12 months, in the opinion of the treating doctor.
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 to distant parts of the body (stage IV disease).
- People with a history of any disease, health problem, or abnormal test result that, in the treating doctor's judgement, suggests a condition that would make the trial treatment unsafe or affect how trial results are understood.
- People with a significant other health condition that, in the treating doctor's judgement, makes it unlikely they would be able to follow all trial requirements.
- People who have had another cancer in the last five years, with some exceptions for certain early-stage or skin cancers, or where a full remission was achieved at least two years before screening with no further treatment needed (confirm with trial site).
- People with a history of a serious ongoing illness that has not been well controlled.
- People with a known allergy or medical reason preventing them from taking the study drug, Elacestrant, or any of its ingredients.
- People with certain serious ongoing medical conditions, including: immune colitis; inflammatory bowel disease; a history of severe vomiting or diarrhoea that has not improved sufficiently; immune pneumonitis; pulmonary fibrosis; certain psychiatric conditions including recent or active suicidal thoughts or behaviour; or significant abnormal blood test results that would make participation unsafe or affect trial results, in the treating doctor's judgement.
- People who have had surgery to remove part of the small intestine or other major surgery on the digestive system.
- People who have an active infection requiring antibiotic treatment at both screening and the baseline visit.
- People with a known history of HIV, AIDS, or multi-drug-resistant bacteria.
- People who test positive for active Hepatitis B or Hepatitis C infection at screening.
- People who are considered to carry a higher-than-normal risk from anaesthesia, for example due to a known or expected difficult airway, if general anaesthetic is needed.
- Women who are pre-menopausal (defined as not having had a hysterectomy and/or removal of both ovaries, or not having had at least 12 months without a period and being at least 50 years old).
- People under 50 years of age.
- People with a known history of drug or substance misuse.
- People who are currently taking part in another clinical trial, or who have done so within 30 days before screening.
- People receiving any other treatment that, in the treating doctor's opinion, might interfere with this trial.
- People who are currently taking strong or moderate medicines that affect a liver enzyme called CYP3A4, either by blocking it or by speeding it up (confirm specific medicines with trial site).
- People currently receiving, or expected to receive during the trial, ongoing treatment with corticosteroids above a low daily dose, immunosuppressive medicines, antibiotics, or any other cancer treatment, within two weeks before trial treatment begins.
- People who are unable to understand the trial requirements, instructions, and restrictions.
- People who are unlikely to follow the trial requirements, for example due to an inability to attend follow-up visits or complete the trial.
- People who do not have full legal capacity to consent.
- People with any condition that, in the treating doctor's judgement, would put them at undue risk during the 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.
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Trial details
Where this trial is recruiting
Primary endpoints
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting; Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting...
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.