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
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).
Cohort
Prospective
Not listed
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.
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.
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.
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.
To correlate the gut microbiome findings with nutritional input.
To correlate the gut microbiome findings with nutritional input.
To correlate the gut microbiome findings with cognitive function.
To correlate the gut microbiome findings with cognitive function.
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This trial is not recruiting at the moment. You can still explore other options:
