CAPTIVATE
Research type
Research Study
Full title
CAPTIVATE: Diet-driven gut microbiome and outcome in patients with early-stage triple-negative breast cancer undergoing neoadjuvant chemotherapy and immunotherapy
IRAS ID
342769
Contact name
Melissa Philips
Contact email
Sponsor organisation
Barts Health NHS Trust
ISRCTN Number
ISRCTN91480159
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Triple-negative breast cancer (TNBC) accounts for approximately 20% of all breast cancers and is defined by the absence of immunostaining for oestrogen receptor, progesterone receptor, and non-amplified HER2 expression. TNBC is associated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane–based systemic chemotherapy. Neoadjuvant chemotherapy (NACT) is the current standard of care for patients with early disease. The short-term goal of NACT is a pathological complete response (pCR), because it is associated with prolonged event-free and overall survival among patients with TNBC. The long-term goal of neoadjuvant plus adjuvant therapy is to prevent the recurrence of metastatic disease. This multi-centre, translational phase II trial aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III triple-negative breast cancer undergoing treatment prior to surgery (neoadjuvant treatment) with and without immunotherapy. As part of the trial, stool samples for the analysis of the gut microbiome will be collected prior to the start of neoadjuvant treatment and at the end of the neoadjuvant treatment. Formalin-fixed paraffin embedded (FFPE) core tumour biopsies will be collected at baseline and at surgery. In patients with residual invasive cancer, a FFPE sample of the residual tumour will also be collected at this point. In a subset of patients (optional), additional snap frozen tumour samples may be collected at baseline and at the time of surgery. Nutritional input and cognitive function will be assessed at baseline, end of chemotherapy and during follow up using validated questionnaires. All data will be correlated with clinical outcome data.
REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0881
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion