Pharmacology of Adjuvant Hormonotherapy in Breast Cancer (PHACS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Institut Claudius Regaud Identifier:
First received: May 18, 2010
Last updated: March 26, 2015
Last verified: March 2015

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: June 2019
Estimated Primary Completion Date: June 2018 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01127295

Clinique Calabet
Agen, France, 47000
Clinique Claude Bernard
Albi, France, 81030
Centre Hospitalier d'Auch
Auch, France, 32008
CHU de Bordeaux
Bordeaux, France, 33000
Clinique Tivoli
Bordeaux, France, 33000
Institut Bergonié
Bordeaux, France, 33076
Polyclinique Bordeaux Nord
Bordeaux, France, 33077
Centre Hospitalier de Brive
Brive La Gaillarde, France, 19312
Centre Hospitalier de Cahors
Cahors, France, 46005
Centre Hospitalier Intercommunal de Castres-Mazamet
Castres, France, 81108
Hôpital Dupuytren CHU Limoges
Limoges, France, 87042
Centre Hospitalier de Mont de Marsan
Mont de Marsan, France, 40024
Centre Hospitalier de Montauban
Montauban, France, 82013
Centre Val d'Aurelle
Montpellier, France, 34298
Hôpital Caremeau CHU Nîmes
Nîmes, France, 30029
Centre Hospitalier de Pau
Pau, France, 64000
Centre Catalan d'Oncologie
Perpignan, France, 66000
Centre Hospitalier de Rodez
Rodez, France, 12000
Polyclinique de l'Ormeau
Tarbes, France, 65000
CHU de Rangueil
Toulouse, France, 31059
Claudius Regaud
Toulouse, France, 31052
Clinique Pasteur - Département d'Oncologie Médicale
Toulouse, France, 31076
Clinique Pasteur - Département de Radiothérapie
Toulouse, France, 31300
Clinique Saint-Jean du Languedoc
Toulouse, France, 31400
Sponsors and Collaborators
Institut Claudius Regaud
Principal Investigator: Henri ROCHE, Pr Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud Identifier: NCT01127295     History of Changes
Other Study ID Numbers: 09 SEIN 09
Study First Received: May 18, 2010
Last Updated: March 26, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses processed this record on November 25, 2015