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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07292142
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
Phase 1
- Adults aged 18 or older.
- People with a confirmed diagnosis of triple-negative breast cancer (TNBC) — a specific type of breast cancer identified by low levels of certain receptors and no HER-2 gene amplification — who are about to begin chemotherapy before surgery.
- People whose general health and ability to function day-to-day falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2).
- People who are willing to provide regular stool and blood samples during the trial.
- People who are able to give written consent to participate.
- People who have tumor biopsy tissue available for laboratory analysis.
Phase 2
- Adults aged 18 or older.
- People with a confirmed diagnosis of triple-negative breast cancer (TNBC) — a specific type of breast cancer identified by low levels of certain receptors and no HER-2 gene amplification — who are about to begin a combination of chemotherapy and immunotherapy before surgery.
- People whose general health and ability to function day-to-day falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2).
- People who are able to give written consent and who understand the infection-related risks associated with a procedure called FMT (faecal microbiota transplantation, where stool from a healthy donor is used to affect gut bacteria).
- People who are able to swallow capsules.
- People taking low-dose steroid medication (no more than 10 mg of prednisone per day, or an equivalent dose of another steroid) may be considered for enrolment.
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.
Phase 1
- People with signs — either physical or shown on scans — that the cancer has spread to other parts of the body.
- People with a known HIV or hepatitis infection.
- People who are pregnant.
Phase 2
- People who have previously received a type of cancer treatment called anti-PD-1 therapy (a type of immunotherapy).
- People who have a second, separate cancer diagnosis.
- People who are pregnant, breastfeeding, or planning to become pregnant during the trial period or within 120 days after the last treatment dose.
- People currently taking high-dose steroid medication (more than 10 mg of prednisone per day, or an equivalent dose). Note: people who occasionally use inhalers or receive steroid injections into a specific area of the body are not excluded on this basis.
- People whose neutrophil count (a measure of a type of infection-fighting blood cell) is below a certain level within 48 hours of a planned FMT procedure (confirm with trial site).
- People with a diagnosed immune system condition — such as HIV or a history of organ transplant — or who are receiving any treatment that suppresses the immune system.
- People currently taking antibiotics, or who have taken antibiotics within one week before the FMT procedure.
- People using probiotic supplements or foods labelled as containing probiotics, unless these have been stopped at least 24 hours before the FMT procedure; probiotics are also not permitted during the immunotherapy treatment period.
- People with a long-term bowel or intestinal condition, such as coeliac disease, malabsorption disorders, or a tumour in the colon.
- People with certain conditions that make FMT unsuitable, including toxic megacolon (a severe bowel complication), serious food allergies (such as to shellfish, nuts, or seafood), or inflammatory bowel disease.
- People expected to need any cancer treatment other than those included in the study while participating in the trial.
- People with an active autoimmune disease, or a documented history of an autoimmune condition that requires steroid or immune-suppressing treatment. (Exceptions include vitiligo, type 1 diabetes, and childhood asthma or allergies that have fully resolved.)
- People who have had a recent episode of lung inflammation (pneumonitis) within the past 30 days that required steroid treatment, or who currently have pneumonitis.
- People with serious ongoing health conditions, such as uncontrolled heart disease, severe lung disease, active systemic infections, inflammatory bowel disorders, HIV/AIDS-related illness, or active hepatitis B or C.
- People with an active infection currently being treated with systemic medication (such as oral or intravenous antibiotics or antifungals).
- People who have received a live vaccine within 4 weeks before the first dose of treatment. Injected flu vaccines are generally allowed, but nasal spray flu vaccines (such as FluMist) are not.
- People with known psychiatric conditions or substance use disorders that would make it difficult to follow the requirements of the trial.
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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jewish General Hospital
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 December 2029
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
To evaluate the safety of combining Fecal Microbial Transplantation (FMT) using intestinal bacteria existing in the stool of healthy donors with immunotherapy/chemotherapy in triple-negative breast cancer patients.; Feasibility of giving FMT is triple negative breast cancer patients treated with chemotherapy / immunotherapy prior surgery.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 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.