MedTrace Logo

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer

NCT01612871 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Florence DALENCr, PhD · Institut Claudius Regaud

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-27
Primary Completion
2016-01-28
Completion
2016-01-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612871 on ClinicalTrials.gov