Triple Negative Breast Cancer (TNBC), Early SettingCAPTIVATENCT07551765
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
An observational study of Triple Negative Breast Cancer (TNBC), Early Setting, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC), Early Setting
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Nov 2026to 1 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through the study completion, an average of 5 years
Secondary outcomes (4)
To correlate microbiome findings with characteristics of CTCAE
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.
Measured: Through the study completion, an average of 5 years.
To correlate the gut microbiome findings with immune-phenotype of the tumour.
To correlate the gut microbiome findings with tumour mutational burden and immune-phenotype of the tumour.
Measured: Through the study completion, an average of 5 years
To correlate the gut microbiome findings with nutritional input.
To correlate the gut microbiome findings with nutritional input.
Measured: Through the study completion, an average of 5 years
To correlate the gut microbiome findings with cognitive function.
To correlate the gut microbiome findings with cognitive function.
Measured: Through the study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start13 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC), Early SettingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Phillips, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551765
- Sponsor's protocol ID
- CAPTIVATE
- Acronym
- CAPTIVATE
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-driven Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
- ClinicalTrials.gov ID
- NCT07551765
- Acronym / sponsor ID
- CAPTIVATE / CAPTIVATE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
To correlate microbiome findings with characteristics of CTCAE
Time frame: 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 nutritional input.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Triple Negative Breast Cancer (TNBC), Early Setting
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Not yet recruitingPhase 3
Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Phillips principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer (TNBC), Early Setting, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CAPTIVATE Study Coordinator (020 7882 8489, bci-captivate@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the changes in the gut microbiome following treatment (time frame: Through the study completion, an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.