Early Phase 1 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 female and between 18 and 75 years old.
- People whose post-surgery tissue testing confirmed a type of breast cancer that is hormone receptor-positive (HR+) and HER2-negative, meaning the cancer responds to hormones but not to the HER2 protein — defined as at least 10% of cancer cells testing positive for estrogen or progesterone receptors, and HER2 showing as 0 or 1+ on standard testing, or negative on a gene-based test.
- People for whom no more than 6 months have passed between their breast surgery (full removal or breast-conserving surgery) and entering the trial.
- People whose post-surgery tissue testing found that cancer had spread to lymph nodes under the arm on the same side as the breast affected (certain other nearby lymph nodes are also considered, with specific counting rules that the trial site can clarify).
- People whose lymph node results meet specific criteria: either 4 or more lymph nodes contained cancer, or 1 to 3 lymph nodes contained cancer along with at least one additional high-risk factor — such as a primary tumour measuring 5cm or larger, a grade III tumour (not grade II-III), remaining invasive cancer after pre-surgery treatment, or a Ki-67 score of 30% or higher (a measure of how fast the cancer cells are growing).
- People with an ECOG performance score of 0 to 2, meaning they are able to carry out everyday activities with little to moderate limitation (confirm with trial site).
- People who have given their written consent and are willing and able to attend scheduled visits, follow the study treatment plan, and complete required tests and procedures.
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 tissue testing shows HER2-positive breast cancer, defined as a score of 3+ on standard immunohistochemistry testing or a positive result on a gene-based test.
- People who have had a local or regional return of breast cancer.
- People whose cancer is classified as stage IV, meaning it has spread to other parts of the body.
- People who have cancer in both breasts, including non-invasive cancer (carcinoma in situ) in the opposite breast.
- People who have a history of serious lung conditions such as interstitial pneumonia.
- People who have previously received treatment with a CDK4/6 inhibitor, or other anti-cancer biological therapies, targeted therapies, or cancer immunotherapy.
- People who have had major surgery, taken an experimental drug, or received other anti-cancer treatments or immune-modifying medicines within the 4 weeks before entering the trial (standard surgery, chemotherapy, radiotherapy, and hormone therapy are exceptions — confirm with trial site).
- People who have other serious physical or mental health conditions, or significant abnormal test results, that in the opinion of the treating doctor could increase risk or affect the reliability of the study results.
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
Phone: 86-13628566285
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
tolerability and safety
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.