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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen, Anastrozole, letrozole, Exemestane | Other | Current hormonotherapy treatment in hormono dependent breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen, Letrozole, Anastrozole or Exemestane | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri ROCHE, Pr | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Calabet | Agen | 47000 | France | |||
| Clinique Claude Bernard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30786012 | Result | 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, Suc E, Sillet-Bach I, Filleron T, Roche H, Chatelut E, White-Koning M, Thomas F. Factors Affecting Tamoxifen Metabolism in Patients With Breast Cancer: Preliminary Results of the French PHACS Study. Clin Pharmacol Ther. 2019 Sep;106(3):585-595. doi: 10.1002/cpt.1404. Epub 2019 Apr 10. | |
| 33047329 |
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| 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 |
| Albi |
| 81030 |
| France |
| Centre Hospitalier d'Auch | Auch | 32008 | France |
| CHU de Bordeaux | Bordeaux | 33000 | France |
| Clinique Tivoli | Bordeaux | 33000 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord | Bordeaux | 33077 | France |
| Centre Hospitalier de Brive | Brive-la-Gaillarde | 19312 | France |
| Centre Hospitalier de Cahors | Cahors | 46005 | France |
| Centre Hospitalier Intercommunal de Castres-Mazamet | Castres | 81108 | France |
| Hôpital Dupuytren CHU Limoges | Limoges | 87042 | France |
| Centre Hospitalier de Mont de Marsan | Mont-de-Marsan | 40024 | France |
| Centre Hospitalier de Montauban | Montauban | 82013 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Hôpital Caremeau CHU Nîmes | Nîmes | 30029 | France |
| Centre Hospitalier de Pau | Pau | 64000 | France |
| Centre Catalan d'Oncologie | Perpignan | 66000 | France |
| Centre Hospitalier de Rodez | Rodez | 12000 | France |
| Polyclinique de l'Ormeau | Tarbes | 65000 | France |
| Claudius Regaud | Toulouse | 31052 | France |
| CHU de Rangueil | Toulouse | 31059 | France |
| Clinique Pasteur - Département d'Oncologie Médicale | Toulouse | 31076 | France |
| Clinique Pasteur - Département de Radiothérapie | Toulouse | 31300 | France |
| Clinique Saint-Jean du Languedoc | Toulouse | 31400 | France |
| Result |
| 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. |
| 38788907 | Result | Puszkiel A, Dalenc F, Tafzi N, Marquet P, Debled M, Jacot W, Venat-Bouvet L, Ferrer C, Levasseur N, Paulon R, Dauba J, Evrard A, Mauries V, Filleron T, Chatelut E, Thomas F, White-Koning M. Identification of non-adherence to adjuvant letrozole using a population pharmacokinetics approach in hormone receptor-positive breast cancer patients. Eur J Pharm Sci. 2024 Aug 1;199:106809. doi: 10.1016/j.ejps.2024.106809. Epub 2024 May 22. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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