NCT07551765Not yet recruiting
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Diet-driven Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 13 Nov 2026
- Primary completion date
- 1 Nov 2032
- Lead sponsor
- Barts & The London NHS Trust
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07551765
What you commit to
- Study type: Observational
- Planned participants: 300
- From 13 Nov 2026 to the primary completion date, 1 Nov 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.