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
- Patients must be female and aged 65 years or older.
- Patients must have been diagnosed with early-stage breast cancer (confirmed by tissue testing) that has been surgically removed, with the cancer testing positive for oestrogen receptors at 50% or higher.
- In addition to the above, patients must also have either 4 or more lymph nodes affected by cancer, OR 1 to 3 affected lymph nodes plus at least one higher-risk feature — such as a high-risk result on a multigene test, a tumour larger than 2 cm, an aggressive tumour grade (grade 3), cancer cells found in blood or lymph vessels near the tumour, or a Ki-67 cell activity level above 20%.
- Patients must be willing to receive a type of hormone-blocking treatment known as a CDK4/6 inhibitor after surgery.
- Patients must have a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning they are fully active to capable of limited self-care).
- Blood test results taken within the past 14 days (without a recent blood transfusion) must show that red blood cells, white blood cells, and platelets are all at acceptable levels.
- Liver function blood tests must be within acceptable limits as set by the trial.
- Kidney function must be within normal range, with an estimated kidney clearance rate above 50 mL/min.
- Patients must be willing to sign a consent form, take part in follow-up appointments, and follow the trial requirements.
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.
- Patients who received any treatment before surgery (such as chemotherapy, targeted therapy, radiation, or hormone therapy) are not eligible.
- Patients who have cancer in both breasts are not eligible.
- Patients with a history of any other cancer are generally not eligible, except for those who have been fully cured of a specific type of skin cancer (basal cell carcinoma) or a very early, non-invasive cervical condition (cervical carcinoma in situ).
- Patients whose cancer has spread to other parts of the body are not eligible.
- Patients with a more advanced local tumour classification (known as T4) — which includes cancer that has grown into the skin, is stuck to surrounding tissue, or is classified as inflammatory breast cancer — are not eligible.
- Patients who are currently taking part in another clinical trial are not eligible.
- Patients with serious heart, lung, liver, or kidney problems are not eligible — this includes a reduced heart pumping function, a major heart or stroke event in the past 6 months, unstable chest pain, uncontrolled high blood pressure (above 150/90 mmHg), poorly controlled diabetes, or severe high blood pressure.
- Patients with a known allergy to a class of chemotherapy drugs called taxanes, or to ingredients used in those medications, are not eligible.
- Patients with a serious or uncontrolled infection are not eligible.
- Patients with a history of abusing mind-altering substances (if unable to stop) or who have a psychiatric condition are not eligible.
- Patients whom the trial doctor considers unsuitable for any reason are not eligible.
- Patients who are unwilling to receive CDK4/6 inhibitor therapy after surgery 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: Zhiming Shao, Fudan University
Phone: +86-021-64175590
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
5-years Invasive disease free survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.