Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment tamoxifen, letrozole , anastrozole, exemestane
Phase phase 4
Sponsor Institut Claudius Regaud
Start date June 2012
End date September 2015
Trial size 39 participants
Trial identifier NCT01612871, 11SEIN12

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day
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

Primary Outcomes

Measure
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)
time frame: 1 time point (D0) over a period of 39 months

Secondary Outcomes

Measure
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)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Women of more than 18 years old (menopausal or not) 2. Women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase +/- LH-RH agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens). 3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (>= 10% of tumor cells by IHC technique). Cancer HER2 negative. 4. Evaluable disease (measurable according RECIST criteria or not) 5. Any previous adjuvant hormone therapy should be discontinued for at least 21 days. 6. One or two prior metastatic lines of chemotherapy are allowed 7. General status WHO 0-2 8. The women of childbearing age must use an effective contraception for the duration of the study 9. Informed consent obtained and signed before any specific study procedure 10. Patient member in a national insurance scheme Exclusion Criteria: 1. Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days. 2. Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer 3. Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer 4. Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy 5. Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator. 6. Patient unable to follow procedures, visits, examinations described in the study. 7. Pregnant women or nursing mothers will not participate in the study. 8. Patients under legal guardianship

Additional Information

Official title Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.
Principal investigator Florence DALENCr, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Institut Claudius Regaud.