Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer, usually treated with chemotherapy and an immune checkpoint blockade (ICB) in the pre-operative or neoadjuvant phase. However, about 35% of tumors do not respond fully to this therapy, and patient prognosis is poor. Recent exciting data from our group and others suggest that the alteration of the gut microbiome via fecal microbiota transplantation (FMT) markedly affects the response to ICB in melanoma1-3. The investigators propose to test the safety and feasibility of altering the gut microbiome in the context of neoadjuvant therapy (NAT) for TNBC. This pilot study will assess the safety of FMT given with neoadjuvant chemo-immunotherapy and will determine the feasibility of conducting a future randomized clinical trial to test whether FMT improves the effectiveness of neoadjuvant chemotherapy and ICB in patients with TNBC. This study will be divided into two phases. In Phase I (observational phase), the investigators propose to test the feasibility of collecting stool and plasma samples in TNBC patients treated with neoadjuvant therapy (NAT) without FMT treatment. In Phase II (interventional phase), patients will undergo the sample collection procedures as in Phase I, but in addition, the investigators will assess the safety and feasibility of FMT treatment in combination with NAT.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
The investigators propose to test the safety and feasibility of altering the gut microbiome in the context of neoadjuvant therapy (NAT) for TNBC. This pilot study will assess the safety of FMT given with neoadjuvant chemo-immunotherapy and will determine the feasibility of conducting a future randomized clinical trial to test whether FMT improves the effectiveness of neoadjuvant chemotherapy and ICB in patients with TNBC.
No FMT will be given in Phase I
London Health Sciences Center
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
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.
Toxicity assessments and concurrent medication review will occur at every visit throughout chemotherapy/immunotherapy treatment. Any adverse events after FMT administration will be followed until resolution or until judged stable by the investigator.
Time frame: 20 months
Feasibility of giving FMT is triple negative breast cancer patients treated with chemotherapy / immunotherapy prior surgery.
The feasibility of FMT in both cohorts will be determined based on the proportion of patients that completed each step of the study. The investigators will assess the proportion approached and declined, approached and consented, consented and withdrew before FMT, consented, screened and successfully took the FMT, and able and willing to provide post-FMT stool samples.
Time frame: 7 months
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