CAPTIVATE Trial Diet Microbiome Triple Negative Breast Cancer
Summary
The NIH has registered NCT07551765, the CAPTIVATE trial, a multi-center observational study examining the impact of diet-driven gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative Breast Cancer undergoing neoadjuvant treatment with and without immune checkpoint inhibitors. The trial will collect stool samples, core tumor biopsies, and research blood samples at various study timepoints for analysis. As an observational registry entry, this posting does not impose compliance obligations on regulated entities.
“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.”
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What changed
The NIH has posted the CAPTIVATE trial (NCT07551765) to ClinicalTrials.gov as an observational registry entry. The study aims to investigate how diet-driven gut microbiome composition affects treatment outcomes in women with untreated, stage I-III Triple Negative Breast Cancer receiving neoadjuvant chemotherapy with and without immune checkpoint inhibitors. Stool samples, tumor biopsies, and research blood samples will be collected at multiple study timepoints.
This registry entry does not create compliance obligations. Healthcare institutions, clinical investigators, and oncology researchers conducting similar microbiome-cancer studies may find CAPTIVATE relevant for protocol design and outcome measurement considerations, but no regulatory action or reporting requirement is imposed by this posting.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Observational NCT07551765 Kind: OBSERVATIONAL Apr 27, 2026
Abstract
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.
Conditions: Triple Negative Breast Cancer (TNBC), Early Setting
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