Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of more than 18 years old (menopause or not).
- •Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
- •Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
- •Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
- •Women of childbearing age must use effective contraception for the duration of the study.
- •Informed consent obtained and signed before any specific procedure in the study.
- •Patient member in a national insurance scheme.
排除标准
- •Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
- •Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
- •Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
- •Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making 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 can not participate in the study.
- •Patients under legal guardianship.
研究组 & 干预措施
Anastrozole
Current hormonotherapy treatment in hormone dependent breast cancer
干预措施: Anastrozole (Drug)
Tamoxifen,
Current hormonotherapy treatment in hormone dependent breast cancer
干预措施: Tamoxifen, (Drug)
Letrozole
Current hormonotherapy treatment in hormone dependent breast cancer
干预措施: Letrozole (Drug)
Exemestane
Current hormonotherapy treatment in hormone dependent breast cancer
干预措施: Exemestane (Drug)
结局指标
主要结局
Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
时间窗: 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.
次要结局
- Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen(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.(2 time points (D0 and D28) over a period of 2 years)