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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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
Centre Val d'Aurelle - Paul Lamarque
Montpellier, France
Institut Claudius REGAUD Toulouse
Toulouse, France
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)
MiRNAs will be quantified in plasma using qPCR (quantitative Polymerase Chain Reaction) with the kit "miScriptSYBR Green PCR" (Qiagen)
Time frame: 1 time point (D0) over a period of 39 months
Analysis of the larger-scale circulating miRNAs in plasma of these patients before (D0) and after one month (D28) of treatment with tamoxifen or anti aromatase
Time frame: 2 time points (D0 and D28) over a period of 39 months (3 years and 3 months)
Correlation between the specific miRNAs initial expression and the appearance of an objective response or clinical benefit of hormone therapy and the time to progression
Time frame: 39 months (3 years and 3 months)
Rate of objective responses, defined as the number of patients with a complete or partial response.
Time frame: 39 months (3 years and 3 months)
The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression
Time frame: 39 months (3 years and 3 months)
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