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Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer (MIRHO)

This study is currently recruiting participants.
Verified May 2013 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01612871
First received: June 4, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Breast Cancer
 Drug: Tamoxifen, Letrozole , Anastrozole, Exemestane
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    MiRNAs will be quantified in plasma using qPCR (quantitative Polymerase Chain Reaction) with the kit "miScriptSYBR Green PCR" (Qiagen)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: June 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hormone therapy treatment
Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612871

Contacts
Contact: Florence DALENC, PhD +33 5.61.42.41.28 Dalenc.florence@claudiusregaud.fr

Locations
France
Centre Val d'Aurelle - Paul Lamarque Recruiting
Montpellier, France, 34298
Contact: Anna DURIGOVA, PhD     +33 4 67 61 31 00     anna.durigova@montpellier.unicancer.fr    
Principal Investigator: Anna DURIGOVA, PhD            
Sub-Investigator: William JACOT, PhD            
Sub-Investigator: Stéphane POUDEROUX, PhD            
Sub-Investigator: Gilles ROMIEU, PhD            
Institut Claudius REGAUD Toulouse Recruiting
Toulouse, France, 31052
Contact: Florence DALENC, PhD     +33 5.61.42.41.28     Dalenc.florence@claudiusregaud.fr    
Sub-Investigator: Laurence GLADIEFF, PhD            
Sub-Investigator: henry ROCHE, PhD            
Sub-Investigator: Jean-Louis LACAZE, PhD            
Principal Investigator: Florence DALENC, PhD            
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Florence DALENCr, PhD Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01612871     History of Changes
Other Study ID Numbers: 11SEIN12
Study First Received: June 4, 2012
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Breast cancer,
hormonotherapy,
miRNAs,
biomarkers
hormone therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Tamoxifen
Anastrozole
Exemestane
Letrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013