Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

Institut Claudius Regaud45 个研究点分布在 1 个国家目标入组 2,000 人2010年6月17日

适应症Hormono-depending Adjuvant Breast Cancer

干预措施Tamoxifen, Letrozole, Anastrozole or Exemestane

概览

阶段: 4 期
干预措施: Tamoxifen, Letrozole, Anastrozole or Exemestane
疾病 / 适应症: Hormono-depending Adjuvant Breast Cancer
发起方: Institut Claudius Regaud
入组人数: 2000
试验地点: 45
主要终点: Correlation between pharmacokinetic and pharmacogenetic parameters
状态: 已完成
最后更新: 18天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.

注册库

clinicaltrials.gov

开始日期

2010年6月17日

结束日期

2017年12月1日

最后更新

18天前

研究类型

Interventional

研究设计

Single Group

性别

Female

研究者

发起方

Institut Claudius Regaud

责任方

Sponsor

入排标准

入选标准

•Patient of more than 18 years old (menopaused or not)
•Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
•Cancer hormone-expressing ER and / or PR (\> 10% tumor cells in Technical HIC)
•Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
•Before the initiation of adjuvant hormonal therapy (tamoxifen, anastrozole, letrozole or exemestane) and whatever the approach chosen by the investigator (5 years of tamoxifen, 5 years of anti-aromatase or sequential patterns)
•signed Consent collected before any specific procedure in the study
•Patient member in a national insurance scheme.

排除标准

•Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
•Metastatic Breast cancer
•History of another cancer diagnosed within 5 years before or uncontrolled except carcinoma in situ of cervix carcinoma, nonmelanoma skin, breast cancer (in this case, treatment with hormone therapy should be stopped for at least 6 months)
•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
•Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment
•Patient under legal guardianship

研究组 & 干预措施

Tamoxifen, Anastrozole, letrozole, Exemestane

Current hormonotherapy treatment in hormono dependent breast cancer

干预措施: Tamoxifen, Letrozole, Anastrozole or Exemestane

结局指标

主要结局

Correlation between pharmacokinetic and pharmacogenetic parameters

时间窗: 9 years

To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.

次要结局

To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment(9 years)
To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.(9 years)
To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)(9 years)
To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.(9 years)
appearance auto-antibody and correlate to the clinical data(9 years)