Clinical trial · Observational
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
Diet-driven Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer (TNBC), Early Setting | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Neoadjuvant Chemotherapy
- description
- Triple-Negative Breast Cancer patients will be treated with neoadjuvant chemotherapy without immunotherapy as the current standard of care for patients with early disease.
- label
- Neoadjuvant Chemotherapy followed with Immune Checkpoint Inhibitors
- description
- 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.
Primary outcomes (2)
- measure
- Determining the changes in the gut microbiome following treatment
- timeFrame
- Through the study completion, an average of 5 years
- description
- To determine if changes in the gut microbiome has the ability to predict the pathologic complete response following treatment.
- measure
- Determining the changes in the gut microbiome following treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available