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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hormone therapy treatment | Experimental | Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen, Letrozole , Anastrozole, Exemestane | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Florence DALENCr, PhD | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Val d'Aurelle - Paul Lamarque | Montpellier | 34298 | France | |||
| Institut Claudius REGAUD Toulouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31297647 | Result | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| 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) |
| Toulouse |
| 31052 |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |