Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.

NCT07551765 | Not Yet Recruiting

• 1 other identifier: CAPTIVATE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Determining the changes in the gut microbiome following treatment

  To determine if changes in the gut microbiome has the ability to predict the pathologic complete response following treatment.

  Through the study completion, an average of 5 years

• Determining the changes in the gut microbiome following treatment

  To determine if changes in the gut microbiome has the ability to predict event free survival following treatment.

  Through the study completion, an average of 5 years

Secondary Outcomes (4)

• To correlate microbiome findings with characteristics of CTCAE

  Through the study completion, an average of 5 years.

• To correlate the gut microbiome findings with immune-phenotype of the tumour.

  Through the study completion, an average of 5 years

• To correlate the gut microbiome findings with nutritional input.

  Through the study completion, an average of 5 years

• To correlate the gut microbiome findings with cognitive function.

  Through the study completion, an average of 5 years

Study Arms (2)

Neoadjuvant Chemotherapy

Triple-Negative Breast Cancer patients will be treated with neoadjuvant chemotherapy without immunotherapy as the current standard of care for patients with early disease.

Neoadjuvant Chemotherapy followed with Immune Checkpoint Inhibitors

Triple-Negative Breast Cancer patients will be treated with neoadjuvant chemotherapy, followed with immunotherapy as the current standard of care for patients with early disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A. Patients with triple-negative early stage breast cancer who will be treated with neoadjuvant chemotherapy. B. Patients with triple-negative early stage breast cancer who will be treated with neoadjuvant chemotherapy followed by immunotherapy (immune checkpoint inhibitors).

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melissa Phillips

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CAPTIVATE Study Coordinator

CONTACT

020 7882 8489; bci-captivate@qmul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: April 27, 2026
• Study Start (Estimated): November 13, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)