drugset / Trial / NCT01553903

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

NCT01553903

Phase 4 Completed 29 enrolled Institut Claudius Regaud
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2011-12
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified 1 mg
Subject Exemestane Small molecule 25 mg
Subject Letrozole Other / unclassified 2.5 mg
Subject Tamoxifen Small molecule 20 mg

Indications