Pharmacology of Adjuvant Hormonotherapy in Breast Cancer (PHACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01127295
First received: May 18, 2010
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hormono-depending Adjuvant Breast Cancer
Drug: Tamoxifen, Letrozole, Anastrozole or Exemestane
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Correlation between pharmacokinetic and pharmacogenetic parameters [ Time Frame: 9 years ] [ Designated as safety issue: No ]
    To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.


Secondary Outcome Measures:
  • To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects. [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
  • To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years) [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations. [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • appearance auto-antibody and correlate to the clinical data [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: May 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tamoxifen, Anastrozole, letrozole, Exemestane
Current hormonotherapy treatment in hormono dependent breast cancer
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127295

Contacts
Contact: Henri ROCHE, Pr + 33 5 61 42 41 30 roche.henri@claudiusregaud.fr

Locations
France
Institut Bergonié Not yet recruiting
Bordeaux, France, 33076
Contact: Hervé BONNEFOI, Pr    + 33 5 56 33 33 44    bonnefoi@bergonie.org   
Principal Investigator: Hervé BONNEFOI, Pr         
Sub-Investigator: Marc DEBLED, Dr         
Sub-Investigator: Louis MAURIAC, Md         
Sub-Investigator: Nicolas MADRANGES, Md         
Hôpital Dupuytren CHU Limoges Not yet recruiting
Limoges, France, 87042
Contact: Nicole TUBIANA, Pr    + 33 5 55 05 55 55    Nicole.Tubiana-Mathieu@chu-limoges.fr   
Principal Investigator: Nicole TUBIANA, Pr         
Sub-Investigator: Pierre MARQUET, Pr         
Centre Val d'Aurelle Not yet recruiting
Montpellier, France, 34298
Contact: Gilles ROMIEU, Md    + 33 4 67 61 31 14    Gilles.Romieu@valdorel.fnclcc.fr   
Principal Investigator: Gilles ROMIEU, Md         
Sub-Investigator: William JACOT, Md         
Sub-Investigator: Stéphane POUDEROUX, Md         
Hôpital Caremeau CHU Nîmes Not yet recruiting
Nîmes, France, 30029
Contact: Pierre MARES, Pr    + 33 4 66 68 68 68    pierre.mares@chu-nimes.fr   
Principal Investigator: Pierre MARES, Pr         
Sub-Investigator: Denis DUPAIGNE, Md         
Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Henri ROCHE, Pr    + 33 5 61 42 42 42    Roche.Henri@claudiusregaud.fr   
Principal Investigator: Henri ROCHE, Pr         
Sub-Investigator: Laurence GLADIEFF, Md         
Sub-Investigator: Ewa-Anna COTURA, Md         
Sub-Investigator: Florence DALENC, Md         
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Henri ROCHE, Pr Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01127295     History of Changes
Other Study ID Numbers: 09 SEIN 09
Study First Received: May 18, 2010
Last Updated: November 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Pharmacokinetics
Pharmacogenetic
tamoxifen
anti-aromatases
breast cancer
pharmacodynamy
Observance

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Exemestane
Letrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014