Stage I-III Triple Negative Breast Cancer Cancer
Conditions
Interventions
This multi-centre, translational phase II trial aims to investigate the impact of the gut microbiome (GM) on treatment outcomes in women with untreated, stage I-III TNBC undergoing neoadjuvant treatme
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent before study entry 2. Female > 18 years of age 3. Histologically confirmed operable primary breast cancer with a tumour size of >1 cm 4. Triple-Negative disease 4.1. Defined as tumours with <10% of tumour cells positive for ER and PR1 on IHC staining or an IHC score (Allred) of £3 4.2. HER2-negative tumours, defined as 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH. 5. Patient planned to undergo neoadjuvant chemotherapy (as per institutional standard) with/without immunotherapy 6. Representative FFPE breast tumour samples with an associated pathology report that are determined to be available and sufficient for central testing OR tumour accessible for biopsy. 7. Ability to comply with the protocol, including but not limited to completion of the patient-reported outcome questionnaires.
Exclusion criteria
Exclusion criteria: 1. Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments) over the last five years. 2. Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation. 3. Known distant metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Association between gut microbiome composition and investigator-assessed pathologic complete response following neoadjuvant chemotherapy ± immunotherapy, measured using microbiome analysis and clinical assessment post-treatment 2. Association between pre- and end-of-treatment gut microbiome composition and event-free survival, measured using microbiome analysis and clinical follow-up at pre-treatment, end-of-treatment, and post-treatment timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Association between gut microbiome composition and occurrence and severity of immune-related adverse events, measured using microbiome analysis and clinical assessment during treatment 2. Association between gut microbiome composition, tumour mutational burden, and pre- and post-treatment immune-phenotype of the tumour, measured using microbiome analysis and tumour profiling at pre- and post-treatment timepoints 3. Association between nutritional input and gut microbiome composition, measured via dietary assessment using the Cancer Council Victoria Dietary Questionnaire for Epidemiological Studies (DQES v3.2) and microbiome analysis during treatment 4. Association between gut microbiome composition and cognitive function, measured using microbiome analysis and cognitive assessment using the PROMIS Perceived Cognitive Function Concerns (PCF) short form questionnaire during treatment | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactMelissa Phillips
Outcome results
None listed