- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01612871
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer (MIRHO)
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.
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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Montpellier, Frankrig, 34298
- Centre Val d'Aurelle - Paul Lamarque
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Toulouse, Frankrig, 31052
- Institut Claudius Regaud Toulouse
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: hormone therapy treatment
Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day
|
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rates of patients for which specific tissular miRNAs are detected in blood before treatment (D0)
Tidsramme: 1 time point (D0) over a period of 39 months
|
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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: 2 time points (D0 and D28) over a period of 39 months (3 years and 3 months)
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2 time points (D0 and D28) over a period of 39 months (3 years and 3 months)
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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
Tidsramme: 39 months (3 years and 3 months)
|
39 months (3 years and 3 months)
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Rate of objective responses, defined as the number of patients with a complete or partial response.
Tidsramme: 39 months (3 years and 3 months)
|
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
Tidsramme: 39 months (3 years and 3 months)
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39 months (3 years and 3 months)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Florence DALENCr, PhD, Institut Claudius Regaud
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Hormonantagonister
- Knogletæthedsbevarende midler
- Aromatasehæmmere
- Steroidsyntesehæmmere
- Østrogenantagonister
- Selektive østrogenreceptormodulatorer
- Østrogenreceptormodulatorer
- Letrozol
- Tamoxifen
- Anastrozol
- Exemestan
Andre undersøgelses-id-numre
- 11SEIN12
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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