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

Phase 4
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)

Outcome Description:

MiRNAs will be quantified in plasma using qPCR (quantitative Polymerase Chain Reaction) with the kit "miScriptSYBR Green PCR" (Qiagen)

Outcome Time Frame:

1 time point (D0) over a period of 39 months

Safety Issue:


Principal Investigator

Florence DALENCr, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2012

Completion Date:

March 2016

Related Keywords:

  • Breast Cancer
  • Breast cancer,
  • hormonotherapy,
  • miRNAs,
  • biomarkers
  • hormone therapy
  • Breast Neoplasms