Phase 4 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
- Women between 18 and 70 years of age.
- People diagnosed with a single breast cancer (not both breasts) that has not spread to distant parts of the body, where the tumour measures at least 1 cm.
- People whose breast cancer test results show: hormone receptors (ER and PR) are less than 10% positive, AND HER-2 results fall into one of the accepted low or negative categories on standard testing (confirm with trial site for exact test results).
- People who have at least one tumour that can be measured using standard imaging guidelines.
- People who have a recent tissue sample (core needle biopsy) from the main tumour available for testing.
- People whose general health and ability to carry out daily activities has been rated as good (score of 0 or 1 on a standard scale) within 10 days before starting the study drug.
- People who are not currently pregnant or breastfeeding, and who either are not able to become pregnant, OR who are able to become pregnant but agree to use strict contraception during treatment and for at least 6 months after the last dose.
- People whose heart, liver, kidneys, and other organs are working well, as shown by recent blood tests and scans.
- People who are willing and able to follow the study plan, understand the research process, and have signed a written consent form.
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 cancer in both breasts, or breast cancer that has spread to other parts of the body (Stage IV).
- People who have had a heart attack, a serious heart event, or certain heart procedures (such as stenting or bypass surgery) within the past 6 months, or who currently have or have previously had significant heart failure.
- People whose immune system is weakened, or who have been taking steroid or immune-suppressing medicines within 7 days before starting the study drug.
- People who have an autoimmune disease (where the immune system attacks the body) that has required ongoing treatment within the past 2 years.
- People with a known history of active tuberculosis.
- People who have had lung inflammation (pneumonitis) that required steroid treatment, or who currently have any type of active lung inflammation.
- People with serious, active infections throughout the body, or other serious illnesses.
- People who have been diagnosed with another cancer in the past 5 years, except for certain cured skin cancers or cervical carcinoma in situ.
- People with a known HIV infection.
- People with an active hepatitis B or hepatitis C infection.
- People with a known allergy or intolerance to any of the medicines used in this trial or their ingredients.
- People who have previously received chemotherapy, hormone therapy, biological therapy, or radiation therapy for any reason.
- People who have previously been treated with certain immune checkpoint or T-cell targeting drugs (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar medicines).
- People who are currently in another clinical trial using an experimental medicine or device, if that treatment was given within the past 4 weeks (or within the past 12 months for experimental cancer or anti-growth treatments).
- People who have received a live vaccine (such as measles, chickenpox, yellow fever, BCG, or nasal flu vaccine) within 30 days before starting the study drug.
- People with a history of mental illness or substance abuse that may affect their ability to follow the trial requirements.
- People who are pregnant or breastfeeding, or people who are able to become pregnant but are unwilling to use strict contraception.
- People considered by the research team to be unsuitable for this study for any other reason.
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: 0086-021-64370045
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Pathologic Complete Response (pCR) Rates
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.