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Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

FMT in Triple Negative Breast Cancer Guided by ctDNA

This study focuses on an aggressive type of breast cancer called Triple Negative Breast Cancer (TNBC). Standard treatments like chemotherapy and immunotherapy don't always work for everyone, with about a third of patients not fully responding. Researchers are exploring if altering the gut bacteria through a treatment called Fecal Microbiota Transplantation (FMT) could improve how well these standard treatments work. This study will first check if FMT is safe to give alongside chemotherapy and immunotherapy. It will also help researchers understand if it's possible to do a larger study later to see if FMT actually makes the treatments more effective for people with TNBC.

At a glance

Status
Not yet recruiting
Phase
PHASE1, PHASE2
Sponsor
Jewish General Hospital
Enrolment target
125
Start
01 Feb 2026
Estimated completion
01 Dec 2031
Breast Cancer

What is this study about?

This study is looking into a type of breast cancer called Triple Negative Breast Cancer (TNBC). This can be a challenging cancer to treat. Usually, patients with TNBC receive strong treatments like chemotherapy and a type of immunotherapy before surgery. Immunotherapy helps your body's own defence system fight the cancer. However, these treatments don't always fully work for everyone, and about 35% of patients don't get the full benefit, which can unfortunately lead to poorer outcomes.

Recent research suggests that the tiny living organisms in our gut, collectively known as gut bacteria or the gut microbiome, might play a big role in how well some cancer treatments work, especially immunotherapy. Scientists have seen promising results in other cancers, like melanoma, where changing the gut bacteria using a treatment called Fecal Microbiota Transplantation (FMT) seemed to improve treatment response.

With this in mind, the researchers want to see if FMT could also help patients with TNBC. This study is designed to be a first step, simply checking if FMT is safe to use alongside the usual chemotherapy and immunotherapy given before surgery for TNBC. They also want to see if it's practical to carry out such a study, with the ultimate goal of potentially proving that FMT can make these life-saving treatments more effective in the future.

Key takeaways

  • This study explores a new approach for Triple Negative Breast Cancer.
  • It combines standard cancer treatment with Fecal Microbiota Transplantation (FMT).
  • The main goals are to check the safety and feasibility of FMT.
  • It aims to see if changing gut bacteria can help improve treatment results.
  • This is an important first step towards potentially better treatments.
  • Participation involves providing samples and, for some, taking FMT capsules.

Who may be eligible?

This study is open to both men and women aged 18 or older. To be considered, you must have been diagnosed with Triple Negative Breast Cancer (TNBC) that has not spread to other parts of your body. You should be about to start chemotherapy, and in the second phase of the study, this will include immunotherapy too. Your general health and fitness level will also be checked to make sure you can take part.

There are also some conditions that would mean you can't join the study. These include if your cancer has spread beyond the breast, if you have certain infections like HIV or hepatitis, or if you are pregnant or breastfeeding. In the second phase, patients who have previously had a specific type of anti-cancer treatment (anti-PD-1) or are taking high doses of steroids won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with Triple Negative Breast Cancer that hasn't spread?
  3. Are you about to start chemotherapy (and immunotherapy for phase 2)?
  4. Are you willing to provide blood and stool samples?
  5. Are you able to swallow capsules (for phase 2)?
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you join this study, it actually has two parts. The first part involves you having your usual cancer treatment without any FMT. During this time, you will be asked to provide some stool (poo) and blood samples regularly. This helps the researchers understand the gut bacteria and other markers in people having standard treatment.

If you join the second part of the study, you will also provide stool and blood samples, but in addition, you will receive Fecal Microbiota Transplantation (FMT). This involves taking capsules containing healthy gut bacteria. You would continue to have your usual chemotherapy and immunotherapy treatments alongside the FMT. The researchers will be carefully monitoring your health and the safety of the FMT during this time. The total duration of your participation will depend on your treatment plan and follow-up.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing valuable information that could help improve future treatments for Triple Negative Breast Cancer. For those in the FMT group, there's a chance, though not guaranteed, that it might help your standard treatments work better. Potential risks associated with FMT include possible discomfort from taking the capsules, and very rarely, there could be risks of infection, which the doctors will explain thoroughly. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • London Health Sciences Center
    Verified postcode
    London, Canada
  • The Ottawa Hospital Cancer Centre
    Verified postcode
    Ottawa, Canada
  • Jewish General Hospital
    Verified postcode
    Montreal, Canada

Common questions

What is Triple Negative Breast Cancer (TNBC)?

TNBC is a type of breast cancer that tests negative for three common markers: oestrogen receptors, progesterone receptors, and HER2 protein. This means it doesn't respond to hormone therapy or HER2-targeted drugs, making treatment more challenging.

What is Fecal Microbiota Transplantation (FMT)?

FMT is a procedure where healthy gut bacteria from a donor are transferred to another person. In this study, it would involve taking capsules by mouth.

Will I still get my usual cancer treatment if I join this study?

Yes, all participants will receive the standard chemotherapy and, in the second phase, immunotherapy, as prescribed for their Triple Negative Breast Cancer.

Why do I need to give stool samples?

Stool samples help the researchers study the gut bacteria (microbiome) and understand how it might change during treatment and if it affects how well the treatments work.

Is this study definitely going to make my cancer treatment better?

This is an early-stage study designed to check safety and feasibility. It's not guaranteed to improve your treatment, but it will help scientists learn if FMT could be a promising option for larger studies in the future.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "FMT in Triple Negative Breast Cancer Guided by ctDNA…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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