NCT01612871

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4 breast-cancer

Timeline
Completed

Started Jun 2012

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

June 27, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2016

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

June 4, 2012

Last Update Submit

April 9, 2026

Conditions

Breast Cancer

Keywords

Breast cancer,hormonotherapy,miRNAs,biomarkershormone therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Secondary Outcomes (4)

  • 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

    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

    39 months (3 years and 3 months)

  • Rate of objective responses, defined as the number of patients with a complete or partial response.

    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

    39 months (3 years and 3 months)

Study Arms (1)

hormone therapy treatment

EXPERIMENTAL

Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day

Drug: Tamoxifen, Letrozole , Anastrozole, Exemestane

Interventions

Tamoxifen, Letrozole , Anastrozole, ExemestaneDRUG

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

hormone therapy treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women of more than 18 years old (menopausal or not)
  • 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).
  • Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (\>= 10% of tumor cells by IHC technique).
  • Cancer HER2 negative.
  • Evaluable disease (measurable according RECIST criteria or not)
  • Any previous adjuvant hormone therapy should be discontinued for at least 21 days.
  • One or two prior metastatic lines of chemotherapy are allowed
  • General status WHO 0-2
  • The women of childbearing age must use an effective contraception for the duration of the study
  • Informed consent obtained and signed before any specific study procedure
  • Patient member in a national insurance scheme

You may not qualify if:

  • Patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
  • Prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
  • Any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
  • Known hypercalcaemia before miRNA dosage at T=0 requiring immediate biphosphonate therapy
  • Patient unable to follow procedures, visits, examinations described in the study.
  • Pregnant women or nursing mothers will not participate in the study.
  • Patients under legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Val d'Aurelle - Paul Lamarque

Montpellier, 34298, France

Location

Institut Claudius REGAUD Toulouse

Toulouse, 31052, France

Location

Related Publications (1)

  • Jacot W, Dalenc F, Lopez-Crapez E, Chaltiel L, Durigova A, Gros N, Lozano N, Lacaze JL, Pouderoux S, Gladieff L, Romieu G, Roche H, Filleron T, Lamy PJ. PIK3CA mutations early persistence in cell-free tumor DNA as a negative prognostic factor in metastatic breast cancer patients treated with hormonal therapy. Breast Cancer Res Treat. 2019 Oct;177(3):659-667. doi: 10.1007/s10549-019-05349-y. Epub 2019 Jul 11.

    PMID: 31297647RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TamoxifenLetrozoleAnastrozoleexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Florence DALENCr, PhD

    Institut Claudius Regaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

June 27, 2012

Primary Completion

January 28, 2016

Study Completion

January 28, 2016

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(2)