Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Hormono-depending Adjuvant Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) WHO <2 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tamoxifen, Anastrozole, letrozole, Exemestane<br>Current hormonotherapy treatment in hormono dependent breast cancer | Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane<br>* Tamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between pharmacokinetic and pharmacogenetic parameters | To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects. |  | 9 years | 
| To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacogenetic, tamoxifen, anti-aromatases, breast cancer, pharmacodynamy, Observance