This trial is active, not recruiting.

Condition hormono-depending adjuvant breast cancer
Treatment tamoxifen, letrozole, anastrozole or exemestane
Phase phase 4
Sponsor Institut Claudius Regaud
Start date May 2010
End date June 2018
Trial size 2000 participants
Trial identifier NCT01127295, 09 SEIN 09


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Current hormonotherapy treatment in hormono dependent breast cancer
tamoxifen, letrozole, anastrozole or exemestane
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

Primary Outcomes

Correlation between pharmacokinetic and pharmacogenetic parameters
time frame: 9 years

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Patient of more than 18 years old (menopaused or not) 2. Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab 3. Cancer hormone-expressing ER and / or PR (> 10% tumor cells in Technical HIC) 4. Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary) 5. WHO <2 6. 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) 7. signed Consent collected before any specific procedure in the study 8. Patient member in a national insurance scheme. Exclusion Criteria: 1. Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme 2. Metastatic Breast cancer 3. 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) 4. 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 5. Patient unable to follow procedures, visits, examinations described in the study 6. Pregnant women or nursing mothers can not participate in the study 7. Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment 8. Patient under legal guardianship

Additional Information

Official title Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
Principal investigator Henri ROCHE, Pr
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Institut Claudius Regaud.