NCT01612871

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum. The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated. The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity. In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen, Letrozole , Anastrozole, Exemestane	Current first line metastatic hormone therapy treatment in hormone dependent breast cancer : Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day

Timeline

• Start date: 2012-06-27
• Primary completion: 2016-01-28
• Completion: 2016-01-28
• First posted: 2012-06-06
• Last updated: 2026-04-14

Locations

2 sites across 1 country: France