Phase 2 Breast Cancer Trial, 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 aged 18 or older (both pre- and post-menopausal) or male breast cancer patients
- People with breast cancer that has spread to other parts of the body (metastatic), with no more than 5 measurable areas of spread
- People whose cancer has been confirmed by biopsy to be hormone receptor-positive and HER2-negative, with oestrogen receptor expression above 10%
- People whose cancer either newly spread at diagnosis and then got worse after one hormonal treatment, or people with previously treated metastatic breast cancer who are now being considered for CDK4/6 inhibitor treatment for the first time
- People whose doctor determines they are eligible for treatment with a CDK4/6 inhibitor combined with an aromatase inhibitor
- People who are well enough to carry out daily activities with little or no limitation (a general health score of 0 or 1 on a standard medical scale)
- People whose blood counts and organ function (blood cells, kidneys, liver, and clotting) meet specific levels measured by blood tests (confirm exact values with trial site)
- People who are able to understand the trial and are willing to sign a consent form
- People who have had both ovaries removed may still be eligible
- Pre-menopausal status and post-menopausal status are each defined by specific medical criteria involving menstrual history and/or hormone blood test results (confirm with trial site)
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 with active connective tissue diseases, such as lupus or scleroderma, that currently require treatment for a flare-up
- People currently receiving chemotherapy, hormonal therapy, or HER2-targeted therapy
- People who have any single tumour lesion larger than 5 cm at its widest point
- People for whom a tissue sample (biopsy) confirming metastatic breast cancer cannot be obtained
- People with a known immune system deficiency, or who have been taking high-dose steroid or other immune-suppressing medications within 7 days before the first study treatment
- People who have or have had another separate cancer that is still active or required treatment within the last 3 years (note: certain treated skin cancers or localised cancers that have been potentially cured are generally not excluded — confirm with trial site)
- People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (note: standard hormone or gland replacement therapies are generally not considered to fall under this exclusion — confirm with trial site)
- People with an active infection that requires medical treatment, or people with a known history of HIV
- People with known psychiatric conditions or substance use issues that would make it difficult to participate in the trial requirements
- People with brain metastases (cancer spread to the brain) that are not well controlled
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: Silvia Formenti, M.D., Weill Medical College of Cornell University
Phone: 646-962-3110
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
Progression free survival (PFS) will be measured
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.