Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

Phase 4

Completed

• Conditions: Hormono-depending Adjuvant Breast Cancer
• Interventions: Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane

• Registration Number: NCT01127295
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Study Start: 2010-06-17
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tamoxifen, Anastrozole, letrozole, Exemestane	Tamoxifen, Letrozole, Anastrozole or Exemestane	Current hormonotherapy treatment in hormono dependent breast cancer

Primary Outcome Measures

Name	Time	Method
Correlation between pharmacokinetic and pharmacogenetic parameters	9 years	To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.

Secondary Outcome Measures

Name	Time	Method
To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment	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
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

Trial Locations

Locations (24)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier d'Auch; 🇫🇷 Auch, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Clinique Calabet; 🇫🇷 Agen, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux Nord; 🇫🇷 Bordeaux, France

Centre Hospitalier de Mont de Marsan; 🇫🇷 Mont de Marsan, France

Hôpital Caremeau CHU Nîmes; 🇫🇷 Nîmes, France

Centre Catalan d'Oncologie; 🇫🇷 Perpignan, France

Centre Hospitalier de Rodez; 🇫🇷 Rodez, France

Polyclinique de l'Ormeau; 🇫🇷 Tarbes, France

Clinique Pasteur - Département d'Oncologie Médicale; 🇫🇷 Toulouse, France

Clinique Pasteur - Département de Radiothérapie; 🇫🇷 Toulouse, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Hospitalier de Pau; 🇫🇷 Pau, France

Claudius Regaud; 🇫🇷 Toulouse, France

CHU de Rangueil; 🇫🇷 Toulouse, France

Clinique Saint-Jean du Languedoc; 🇫🇷 Toulouse, France

Centre Hospitalier de Brive; 🇫🇷 Brive La Gaillarde, France

Centre Hospitalier de Cahors; 🇫🇷 Cahors, France

Centre Hospitalier Intercommunal de Castres-Mazamet; 🇫🇷 Castres, France

Hôpital Dupuytren CHU Limoges; 🇫🇷 Limoges, France

Centre Hospitalier de Montauban; 🇫🇷 Montauban, France