Institut Claudius REGAUD
Toulouse, 31052, France
NCT Number: NCT01553903
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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Notify Me18 year and older
Female
Interventional
Phase 4
Toulouse, 31052, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tamoxifen 20 mg/day during 5 years,
Exemestane 25mg/day during 5 years
Anastrozole 1 mg/day during 5 years,
Letrozole 2.5 mg/day during 5 years,
Time frame: 2 time points (D0 and D28) over a period of 2 years
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.
Time frame: 2 time points (D0 and D28) over a period of 2 years
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)
Time frame: 2 time points (D0 and D28) over a period of 2 years
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).
Institut Claudius Regaud
Other
Acronym: OXYTAM
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