Fecal Microbiota Transplantation for Breast Cancer
(FRIDA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to enhance treatment for triple-negative breast cancer (TNBC), a challenging cancer to treat. Researchers are testing whether fecal microbiota transplantation (FMT) can safely and feasibly improve the effectiveness of standard chemo-immunotherapy, which some TNBC patients do not fully respond to. Initially, the trial observes patients undergoing standard treatment, then tests the addition of FMT to assess its impact. Individuals with TNBC who are about to start chemo-immunotherapy and can provide stool samples might qualify for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in TNBC treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use antibiotics one week before the FMT procedure or during the trial. Also, probiotic supplements and foods with probiotics must be stopped 24 hours before FMT and during the treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that fecal microbiota transplantation (FMT) could aid in cancer treatment. Studies have found that FMT can reduce some negative effects of cancer treatments like chemotherapy. For example, it helps protect the intestines from damage and boosts the immune system's ability to fight cancer. In cancer care, FMT has been used to enhance patient responses to immunotherapy, especially for conditions like melanoma.
Regarding safety, research suggests that FMT is generally well-tolerated, with most people not experiencing serious side effects. However, because this treatment is still under study, specific information about its use in breast cancer patients remains limited. In other cases, some people have reported mild digestive issues after FMT, but these usually resolve quickly.
Since this trial is in its early stages, the main goal is to determine if FMT is safe to use with current breast cancer treatments. This phase of testing often means limited information on long-term effects, but early results are promising in terms of safety. Always consult a healthcare provider to understand the potential risks and benefits.12345Why are researchers excited about this trial's treatment?
Researchers are excited about fecal microbiota transplantation (FMT) for breast cancer, specifically triple-negative breast cancer (TNBC), because it represents a novel approach that leverages the gut microbiome to potentially enhance the effects of existing therapies. Unlike traditional treatments like chemotherapy and immunotherapy, FMT involves transferring healthy bacteria from a donor’s stool to the patient, which may improve the body's response to cancer treatments by altering the gut flora. This approach is groundbreaking because it could provide a new avenue for boosting the effectiveness of current cancer therapies, potentially leading to better outcomes for patients with TNBC, a particularly aggressive form of breast cancer.
What evidence suggests that fecal microbiota transplantation could be an effective treatment for triple-negative breast cancer?
Research shows that altering gut bacteria through fecal microbiota transplantation (FMT) can influence the effectiveness of cancer treatments. Studies have found that patients with a greater diversity of gut bacteria often respond better to treatments like immunotherapy. FMT has been linked to stronger immune responses in cancer patients, offering promise for treating triple-negative breast cancer (TNBC). Experiments with mice demonstrated that FMT from patients who responded well to cancer treatment can enhance the body's ability to fight tumors. This trial examines FMT in combination with standard chemotherapy and immunotherapy for TNBC. While direct evidence in TNBC is still under investigation, these findings suggest FMT might improve patient responses to combined chemotherapy and immunotherapy.14678
Are You a Good Fit for This Trial?
This trial is for individuals with triple-negative breast cancer (TNBC) who are undergoing pre-operative or neoadjuvant therapy. The study aims to see if altering the gut microbiome can improve treatment response. Participants must be eligible for neoadjuvant chemo-immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I (Observational)
Feasibility of collecting stool and plasma samples in TNBC patients treated with neoadjuvant therapy without FMT treatment
Phase II (Interventional)
Safety and feasibility of FMT treatment in combination with neoadjuvant therapy, including exploratory analyses of tumor response markers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplantation (FMT)
Trial Overview
The trial is testing fecal microbiota transplantation (FMT) alongside standard chemotherapy and immune checkpoint blockade in TNBC patients. It's a two-phase study: Phase I observes sample collection without FMT, and Phase II adds FMT to assess safety and feasibility.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Phase II aims to assess the safety and feasibility of adding FMT to the treatment regimen of patients with TNBC receiving standard of care neoadjuvant chemotherapy plus immunotherapy. As this FMT regimen has never been combined with chemo-immunotherapy in TNBC, the goal is to assess safety and feasibility first. Exploratory analyses of markers of tumor response (ctDNA and pCR rate) and gut microbiome will also be conducted before embarking on a larger study. Phase II will comprise two cohorts. In Cohort 2, patients with ctDNA+ persistence from baseline to post-cycle 1 NAT (high-risk of non-pCR) will receive "rescue" FMT therapy at mid-treatment of NAT.
Phase II aims to assess the safety and feasibility of adding FMT to the treatment regimen of patients with TNBC receiving standard of care neoadjuvant chemotherapy plus immunotherapy. As this FMT regimen has never been combined with chemo-immunotherapy in TNBC, the goal is to assess safety and feasibility first. Exploratory analyses of markers of tumor response (ctDNA and pCR rate) and gut microbiome will also be conducted before embarking on a larger study. Phase II will comprise two cohorts. Cohort 1 will be administering FMT before starting standard systemic anti-cancer therapy, in this case, NAT for early TNBC.
In preparation for Phase II of the protocol, Phase I of the study will evaluate the feasibility of stool and plasma sample collection at different time points in TNBC patients receiving standard of care NAT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jewish General Hospital
Lead Sponsor
Citations
FMT in Triple Negative Breast Cancer Guided by ctDNA
To evaluate the safety of combining Fecal Microbial Transplantation (FMT) using intestinal bacteria existing in the stool of healthy donors with immunotherapy/ ...
Gut microbiota reshapes the TNBC immune ...
These studies revealed that reduced microbial diversity or richness in fecal samples was linked to poorer therapeutic responses and shorter survival times [75].
Characterization of Gut Microbiome Composition in Patients ...
... fecal samples collection at 3 timepoints for TNBC patients undergoing neoadjuvant chemotherapy. We aimed at obtaining an 80% rate of ...
Fecal microbiota transplantation to enhance cancer ...
This systematic review evaluates Fecal Microbiota Transplantation (FMT)'s impact on cancer treatment outcomes and treatment-related toxicity and explores its ...
Antimicrobial exposure is associated with decreased ...
Germ-free tumor-bearing mice that received fecal microbiome transplants from patients who responded to ICIs demonstrated increased tumor immune ...
Fecal microbiota transplantation to enhance cancer ...
The gut microbiome is increasingly recognized as a critical modulator of cancer therapy response. This systematic review evaluates Fecal Microbiota ...
Understanding and harnessing triple-negative breast cancer ...
Fecal microbiota transplantation prevents intestinal injury, upregulation of toll-like receptors, and 5-fluorouracil/oxaliplatin-induced ...
Fecal microbial transplants as investigative tools in cancer
Patient studies have found varied levels of success with FMT treatment, ranging from 44% to 73% remission of UC as part of the lyophilized oral fecal microbiota ...
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