Breast Cancer - Borstkanker Microbiota - Darmbacteriën Estrogen - Oestrogeen Hormone therapy - Hormonale therapie
Conditions
Interventions
No interventions
Observational study
Sponsors
Maastricht University Medical Center (MUMC+)
Eligibility
Inclusion criteria
Inclusion criteria: • Postmenopausal estrogen receptor positive breast cancer patients in curative setting starting with hormone therapy with either aromatase inhibitors or tamoxifen • Willing and able to undergo all study procedures • Signed informed consent
Exclusion criteria
Exclusion criteria: • HER2+ breast cancer • Metastatic disease • Systemic therapy during previous month, except tamoxifen • Prior therapeutic antibiotic use in last 3 months • Physically or mentally incapable or incompetent to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is microbiota composition before and during (after 6 – 12 weeks) systemic hormone therapy in relation to systemic estrogen and endoxifen levels in respectively the cohort treated with aromatase inhibitors and tamoxifen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include absolute microbiota abundance, ß-glucuronidase activity and estrogen metabolites before and during (after 6 – 12 weeks) systemic hormone therapy. Other study parameters includes tumour grade, presence of genetic mutation, compliance score, performance score, MUST score, patient (abdominal) history and history of smoking, antibiotic use, contraceptive use, adverse events and serious adverse events. | — |
Contacts
Public ContactR Aarnoutse
Maastricht University Medical Center +, Department of Surgery
Outcome results
None listed