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

The role of intestinal microbiota in breast cancer treatment with hormone therapy: a pathway to new therapeutic options - Intestinal microbiota in breast cancer patients treated with hormonetherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53061

Enrollment

Registered

2017-08-30

Start date

2017-10-19

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoints include, the microbiota composition before and during systemic hormone therapy. Further, microbiota composition in relation to systemic estrogen and endoxifen levels will be analysed.	—

Secondary

Measure	Time frame
Secondary endpoints include absolute microbiota abundance, ß-glucuronidase activity. Estrogen metabolites during tamoxifen therapy will be quantified. Furthermore, the CYP polymorphism will be quantified.	—

Countries

Netherlands

Outcome results