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, sign a consent form, and follow the study requirements.
- People aged 18 to 75 years old at the time of signing the consent form.
- People with a good general health and activity level (ECOG performance score of 0–1) and an expected survival of more than 6 months.
- People who have been diagnosed with primary breast cancer confirmed by tissue or cell testing.
- People whose primary breast tumour measures more than 2 cm across, based on standard local assessment.
- People whose breast cancer has been assessed by the investigator as meeting a specific staging range (cT2–cT4, cN0–cN3, cM0) under internationally recognised breast cancer staging guidelines, with locally advanced or early-stage, one-sided, invasive breast cancer.
- People with early-stage triple-negative invasive breast cancer confirmed by tissue testing, as defined by the latest professional guidelines.
- People who have at least one tumour that can be measured according to standard criteria (RECIST 1.1).
- People who agree to undergo breast cancer surgery if they meet the surgical requirements after completing pre-surgery treatment.
- People whose PD-L1 expression status (a marker on tumour cells) has already been tested and is known.
- People whose major organ functions (such as heart, liver, and kidneys) are in good working condition.
- Female participants who could become pregnant must have a negative blood pregnancy test within 3 days before the first dose, and must use an accepted and effective form of contraception from the screening period until 12 months after the last dose — note that periodic abstinence and rhythm methods are not considered acceptable for this trial.
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 stage IV breast cancer that has spread to other parts of the body, or those the investigator considers unable to achieve curative surgery through pre-surgery treatment.
- People with inflammatory breast cancer.
- People who have had or currently have another cancer diagnosis within the past 3 years — though two exceptions may apply: another cancer treated with surgery alone that has been free of disease for at least 5 years continuously; or a history of cervical carcinoma in situ, non-melanoma skin cancer, or certain superficial bladder tumours that have been cured (confirm with trial site).
- People who have received anti-cancer treatments such as chemotherapy, hormone therapy, or immune checkpoint inhibitor therapy in the past 3 years, or who have had breast surgery other than a diagnostic biopsy.
- People who have had major surgery, a surgical tissue biopsy (other than a diagnostic biopsy for primary breast cancer), or a serious injury within 28 days before the start of the study treatment.
- People who have an active autoimmune disease or a history of autoimmune disease.
- People who are currently using medicines that suppress the immune system, or taking steroid medications at a dose greater than 10 mg per day of prednisone (or equivalent), and have continued this treatment within 2 weeks before enrolling.
- People who have a known allergy to any of the study drugs or their ingredients.
- People with other health conditions that the investigator considers a serious risk to their safety or that may prevent them from completing the study.
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: Yongsheng Jia, Tianjin Medical University Cancer Institute and Hospital
Phone: +86 18622199359
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
tpCR(ypT0/is ypN0)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.