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.
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
defined as tumours with <10% of tumours cells positive for ER and PR1 on IHC staining or an IHC score (Allred) < 3
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