Diet-drive 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.

NCT Number	NCT07551765
Lead Sponsor	Barts & The London NHS Trust
Conditions	Triple Negative Breast Cancer (TNBC), Early Setting
Enrollment	300 participants
Start Date	2026-11-13
Primary Completion	2032-11-01 (estimated)
Study Completion	2032-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-27