Gut check: could your microbiome predict cancer treatment success?
NCT ID NCT07551765
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how diet and gut bacteria affect treatment outcomes in women with early-stage triple-negative breast cancer. Researchers will collect stool, blood, and tumor samples from 300 participants before, during, and after chemotherapy and immunotherapy. The goal is to see if changes in the gut microbiome can predict whether the cancer disappears completely after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors predict which patients will respond best to treatment and potentially guide dietary recommendations to improve outcomes.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test a new therapy, and results may take years to translate into clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A. Patients with triple-negative early stage breast cancer who will be treated with neoadjuvant chemotherapy. B. Patients with triple-negative early stage breast cancer who will be treated with neoadjuvant chemotherapy followed by immunotherapy (immune checkpoint inhibitors).
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to provide written informed consent prior to study entry * Female ≥ 18 years of age * Histologically confirmed operable primary breast cancer with a tumor size of ≥1 cm * Triple-negative disease: * defined as tumours with \<10% of tumours cells positive for ER and PR1 on IHC staining or an IHC score (Allred) \< 3 * HER2-negative tumours defined as 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH. defined as tumours with * Patient planned to undergo neoadjuvant chemotherapy (as per institutional standard) with/without immunotherapy * Representative formalin-fixed paraffin embedded (FFPE) breast tumours samples with an associated pathology report that are determined to be available and sufficient for central testing OR tumours accessible for biopsy. * Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcomes questionnaires Exclusion Criteria: Patients meeting any of the following exclusion criteria are not be enrolled in the study. * Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments) * Received therapeutic oral or intravenous antibiotics within 14 days prior to randomization * Known distant metastases
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barts Health NHS Trust
London, United Kingdom
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