The role of intestinal microbiota in breast cancer treatment with hormone therapy: a pathway to new therapeutic options

• Conditions: Breast Cancer - BorstkankerMicrobiota - DarmbacteriënEstrogen - OestrogeenHormone therapy - Hormonale therapie

• Registration Number: NL-OMON20717
• Lead Sponsor: Maastricht University Medical Center (MUMC+)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 132

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

Exclusion Criteria

•HER2+ breast cancer

•Metastatic disease

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary endpoints include absolute microbiota abundance, ß-glucuronidase activity and estrogen metabolites before and during (after 6 – 12 weeks) systemic hormone therapy.<br /><br><br /><br>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.