Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

NCT ID: NCT01127295

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-17
• Study Completion Date: 2017-12-01

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.

Conditions

Hormono-depending Adjuvant Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tamoxifen, Anastrozole, letrozole, Exemestane

Current hormonotherapy treatment in hormono dependent breast cancer

Group Type: OTHER

Tamoxifen, Letrozole, Anastrozole or Exemestane

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri ROCHE, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Clinique Calabet

Agen, , France

Clinique Claude Bernard

Albi, , France

Centre Hospitalier d'Auch

Auch, , France

CHU de Bordeaux

Bordeaux, , France

Clinique Tivoli

Bordeaux, , France

Institut Bergonié

Bordeaux, , France

Polyclinique Bordeaux Nord

Bordeaux, , 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 Mont de Marsan

Mont-de-Marsan, , France

Centre Hospitalier de Montauban

Montauban, , France

Centre Val d'Aurelle

Montpellier, , France

Hôpital Caremeau CHU Nîmes

Nîmes, , France

Centre Hospitalier de Pau

Pau, , France

Centre Catalan d'Oncologie

Perpignan, , France

Centre Hospitalier de Rodez

Rodez, , France

Polyclinique de l'Ormeau

Tarbes, , France

Claudius Regaud

Toulouse, , France

CHU de Rangueil

Toulouse, , France

Clinique Pasteur - Département d'Oncologie Médicale

Toulouse, , France

Clinique Pasteur - Département de Radiothérapie

Toulouse, , France

Clinique Saint-Jean du Languedoc

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38788907 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33047329 (View on PubMed)

Other Identifiers

09 SEIN 09

Identifier Type: -

Identifier Source: org_study_id