Clinical trial NCT01127295: Pharmacology of Adjuvant Hormonotherapy in Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hormono-depending Adjuvant Breast Cancer
Keywords: Pharmacokinetics
Pharmacogenetic
tamoxifen
anti-aromatases
breast cancer
pharmacodynamy
Observance
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between pharmacokinetic and pharmacogenetic parameters
timeFrame: 9 years
Secondary outcomes:
measure: To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects.
timeFrame: 9 years
measure: To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment
timeFrame: 9 years
measure: To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years)
timeFrame: 9 years
measure: To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations.
timeFrame: 9 years
measure: appearance auto-antibody and correlate to the clinical data
timeFrame: 9 years
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Calabet
city: Albi
country: France
facility: Clinique Claude Bernard
city: Auch
country: France
facility: Centre Hospitalier d'Auch
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Brive La Gaillarde
country: France
facility: Centre Hospitalier de Brive
city: Cahors
country: France
facility: Centre Hospitalier de Cahors
city: Castres
country: France
facility: Centre Hospitalier Intercommunal de Castres-Mazamet
city: Limoges
country: France
facility: Hôpital Dupuytren CHU Limoges
city: Mont de Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nîmes
country: France
facility: Hôpital Caremeau CHU Nîmes
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Toulouse
country: France
facility: Claudius Regaud
city: Toulouse
country: France
facility: CHU de Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur - Département d'Oncologie Médicale
city: Toulouse
country: France
facility: Clinique Pasteur - Département de Radiothérapie
city: Toulouse
country: France
facility: Clinique Saint-Jean du Languedoc
Study officials:
affiliation: Institut Claudius Regaud
name: Henri ROCHE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roche H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.