Gut bacteria and treatment results in early triple-negative breast cancer
Studies how gut bacteria relate to treatment outcomes in women with early triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Key facts
- Where
- London, United KingdomSee the site
Where in United Kingdom
- Barts Health NHS TrustLondon, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Barts & The London NHS Trust
- Trial code
- NCT07551765
- Record updated
- 27 April 2026
- Original description
CAPTIVATE is a multi-center translational and observational trial, that aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative undergoing neoadjuvant treatment with and without immune checkpoint inhibitors. As part of the trial, stool samples, core tumors biopsies and research bloods samples for the analysis will be collected at various points of the study.Read full original descriptionShow less
Diet-driven Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
CAPTIVATE is a multi-center translational and observational trial, that aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative undergoing neoadjuvant treatment with and without immune checkpoint inhibitors. As part of the trial, stool samples, core tumors biopsies and research bloods samples for the analysis will be collected at various points of the study.
Inclusion: 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.