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This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.
Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.
The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen, | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer |
|
| Exemestane | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer |
|
| Anastrozole | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer |
|
| Letrozole | Experimental | Current hormonotherapy treatment in hormone dependent breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen, | Drug | Tamoxifen 20 mg/day during 5 years, |
| |
| Exemestane |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human. | Oxysterols measured are the following : OCDO (6-oxo-cholestan-3 beta, 5 alpha-diol), CE (cholesterol-5,6-eposides) and CT (cholestane-3 beta, 5 alpha, 6 beta-triol). Calibration curve will be established for each Oxysterol by GC/MS using deuterated analogues of each oxysterols for the quantification. | 2 time points (D0 and D28) over a period of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen | Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with Tamoxifen in order to determine the impact of the treatment on these plasmatic concentrations(D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence DALENC, MD | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Claudius REGAUD | Toulouse | 31052 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27343991 | Result | Dalenc F, Iuliano L, Filleron T, Zerbinati C, Voisin M, Arellano C, Chatelut E, Marquet P, Samadi M, Roche H, Poirot M, Silvente-Poirot S. Circulating oxysterol metabolites as potential new surrogate markers in patients with hormone receptor-positive breast cancer: Results of the OXYTAM study. J Steroid Biochem Mol Biol. 2017 May;169:210-218. doi: 10.1016/j.jsbmb.2016.06.010. Epub 2016 Jun 22. |
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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 |
| C056516 | exemestane |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
Exemestane 25mg/day during 5 years |
|
| Anastrozole | Drug | Anastrozole 1 mg/day during 5 years, |
|
| Letrozole | Drug | Letrozole 2.5 mg/day during 5 years, |
|
| 2 time points (D0 and D28) over a period of 2 years |
| Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase. | Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with anti-aromatase (Anastrozole, Letrozole or Exemestane) in order to determine the absence of impact of the treatment on these plasmatic concentrations (D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations). | 2 time points (D0 and D28) over a period of 2 years |
| 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 |