The role of intestinal microbiota in breast cancer treatment with hormone therapy: a pathway to new therapeutic options
Completed
- Conditions
- Breast cancer1000629110006232
- Registration Number
- NL-OMON53061
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
* Postmenopausal estrogen receptor positive breast cancer patients in curative
setting starting with tamoxifen
* Willing and able to undergo all study procedures
* Signed informed consent
Exclusion Criteria
* HER2+ breast cancer
* Metastatic disease (M+)
* Systemic therapy during previous month
* Prior therapeutic antibiotic use in last 3 months
* Physically or mentally incapable or incompetent to sign informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints include, the microbiota composition before and during<br /><br>systemic hormone therapy. Further, microbiota composition in relation to<br /><br>systemic estrogen and endoxifen levels will be analysed. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include absolute microbiota abundance, ß-glucuronidase<br /><br>activity. Estrogen metabolites during tamoxifen therapy will be quantified.<br /><br>Furthermore, the CYP polymorphism will be quantified.</p><br>