Printed from Voxsanity (voxsanity.com.au) — NCT07552181 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07552181
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
- Adults aged 18 or older (male or female).
- People diagnosed with high-risk, early-stage triple negative breast cancer, where the cancer tests negative for certain hormone receptors and a protein called HER2.
- People whose cancer meets specific staging criteria based on tumour size and whether nearby lymph nodes are affected, with no spread to distant parts of the body.
- People willing to provide tissue samples from an initial biopsy and from any remaining tumour removed during surgery.
- People with a good general performance level, able to carry out normal daily activities with little or no limitation (confirm with trial site).
- People with adequate organ function, confirmed by tests taken within 28 days before starting treatment.
- For one specific treatment group only: People with healthy heart function, with the heart pumping at 50% capacity or above, confirmed by a heart scan within 28 days before starting treatment; people with a known heart condition history must meet a specific heart health classification level (confirm with trial site).
- Women who could become pregnant must have a negative pregnancy test within 28 days before starting treatment.
- Male participants must agree to use contraception during treatment and for at least 120 days after the last dose of the study drug, and must not donate sperm during this period.
- Female participants must either not be of childbearing potential, or must agree to use effective contraception during the study and for 120 days after the last dose of the study drug, and must not be pregnant or breastfeeding.
- People who are willing and able to give written consent and follow the requirements of the study.
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 living with HIV who are not on effective treatment or whose virus is not at an undetectable level based on a test within the past 6 months.
- People with a chronic hepatitis B infection whose virus is not at an undetectable level while on the appropriate treatment, based on a test within the past 6 months (testing may only be required if directed by local health authorities).
- People with diabetes or high blood pressure that is not well controlled, in the opinion of the treating doctor.
- People who have had major surgery within the 14 days before screening.
- People who have had a severe infection within the 14 days before enrolling.
- People who have received any chemotherapy, biological therapy, or immunotherapy for their current breast cancer diagnosis before starting the study.
- People who have previously used immune checkpoint inhibitor treatments.
- People who have already had breast surgery or radiation therapy for their current invasive breast cancer.
- People with an immune deficiency condition who are taking steroid medication at higher than a certain daily dose, or any other medication that suppresses the immune system, within 7 days before enrolling.
- People with an active autoimmune disease that has needed systemic medical treatment within the past 2 years (note: routine hormone or hormone-like replacement therapies are not considered systemic treatment in this context).
- People with a history of non-infectious lung inflammation that required steroid treatment, or who currently have this condition.
- People who have received a live vaccine within 30 days before the first dose of the study drug, or who would need one within 3 months after completing the immunotherapy part of treatment — this includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid; certain nasal flu vaccines are also included, though standard injected flu vaccines are generally permitted (confirm with trial site).
- People currently taking warfarin (certain other blood-thinning medications are permitted — confirm with trial site).
- People using other live biotherapeutic products or probiotic supplements in pill form during the study (such as certain commercial probiotic products).
- People who are currently taking part in, or have taken part in, another study involving an investigational drug or device within the 4 weeks before the first dose.
- People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 120 days after the last dose.
- People with a known allergy to any ingredients in the study medications, including corn starch, lactose, microcrystalline cellulose, croscarmellose sodium, or magnesium stearate.
- People with a history of another cancer, except for certain treated skin cancers, treated early-stage cancers currently in full remission, or any cancer from which the person has been cancer-free for at least five years.
- People with active cancer that has spread to the brain or the lining of the brain; people with previously treated and stable brain metastases may be considered if they meet specific stability and treatment criteria (confirm with trial site).
- People with a known history of active tuberculosis (TB).
- People with another ongoing or past medical condition that the investigating doctor considers would increase the risk of participating.
- People with known psychiatric conditions or substance use disorders that would interfere with participation in the trial.
- People who have received an organ or tissue transplant from another person.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Yuan Yuan, MD, Cedars-Sinai Medical Center
Phone: 3104232133
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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Yuan Yuan
Registry
ClinicalTrials.gov
Start date
1 September 2026
Est. completion
1 September 2035
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Pathological Complete Response (pCR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.