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

April 20, 2026 updated by: Barts & The London NHS Trust

Diet-driven 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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The current standard of care for patients with early disease triple-negative breast cancer is neoadjuvant chemotherapy. The addition of the immune checkpoint inhibitor (ICI) to this the NACT treatment regimen has recently been shown to substantially improve the outcome of this patient population. Several translational studies have suggested the potential influence of the gut microbiome in modulating the efficacy of ICI-based therapies. In addition to the influence on response to ICI, several studies also suggest a strong association between the gut microbiome and side effects with ICI therapy.

The aim of this prospective longitudinal study is to investigate the complex interactions between the gut microbiome, the tumour biology of early-stage triple negative breast cancer, the efficacy and tolerability of neoadjuvant chemotherapy (NACT) followed by immune checkpoint inhibitors, including the possible impact on the cognitive function and the long-term outcome. A specific focus will be to study the association of the gut microbiome and the risk of breast cancer recurrence in the high-risk group of patients with residual disease after NACT. The study will furthermore assess dynamic changes in both the gut microbiome and the tumour biology, and their association with long-term outcome. Furthermore, the association of nutritional input and the gut microbiome will be studied. Results of this trial might be the basis for future interventional studies that might stratify treatment modalities based on the gut microbiome or attempt to modulate treatment outcomes through targeting the gut microbiome.

At least 200 patients undergoing neoadjuvant chemotherapy plus immunotherapy and at least 100 patients undergoing neoadjuvant chemotherapy alone will be recruited into the study.

The study poses very little risk for research participants; blood samples and faecal samples are routinely performed in hospitals.

Informed consent will be obtained prior to the participants undergoing procedures that are specifically for the purposes of the study and our outside standard, routine care at participating sites. Ample time will be given for consideration by the patient before taking part. Written informed consent will only be obtained from those who the Investigator feels assured have understood the implications of participation in the study.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the changes in the gut microbiome following treatment
Time Frame: Through the study completion, an average of 5 years
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
Time Frame: Through the study completion, an average of 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate microbiome findings with characteristics of CTCAE
Time Frame: Through the study completion, an average of 5 years.
To correlate microbiome findings with incidence and characteristics of CTCAE (Common Terminology Criteria for Adverse Events) V-5 defined Grade > 3 irAEs in all enrolled patients, and any association with response to immunosuppressants.
Through the study completion, an average of 5 years.
To correlate the gut microbiome findings with immune-phenotype of the tumour.
Time Frame: Through the study completion, an average of 5 years
To correlate the gut microbiome findings with tumour mutational burden and immune-phenotype of the tumour.
Through the study completion, an average of 5 years
To correlate the gut microbiome findings with nutritional input.
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Investigators

  • Principal Investigator: Melissa Phillips, Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 13, 2026

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2032

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPTIVATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Triple Negative Breast Cancer (TNBC), Early Setting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe