Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Starting soon
Conditions studied: Triple Negative Breast Cancer (TNBC), Early Setting
In brief
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.
Key facts
- Study ID
- NCT07551765
- Run by
- Barts & The London NHS Trust
- People needed
- 300
- Starts
- 2026-11-13
- Expected to finish
- 2032-11-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Barts Health NHS Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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