We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Pharmacology of Adjuvant Hormonotherapy in Breast Cancer (PHACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01127295
Recruitment Status : Active, not recruiting
First Posted : May 20, 2010
Last Update Posted : March 31, 2015
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Correlation between pharmacokinetic and pharmacogenetic parameters [ Time Frame: 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 :
  1. To estimate the relation between plasmatic concentrations, pharmacogenetic characteristic and adverse effects. [ Time Frame: 9 years ]
  2. To estimate the relation between the genetic polymorphisms and premature relapses in the first 3 years of treatment [ Time Frame: 9 years ]
  3. To estimate the link between plasmatic concentrations and the premature relapse (in the first 3 years) [ Time Frame: 9 years ]
  4. To estimate the declared therapeutic observance to the real exposure at the treatment measured by plasmatic concentrations. [ Time Frame: 9 years ]
  5. appearance auto-antibody and correlate to the clinical data [ Time Frame: 9 years ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Claudius Regaud
Toulouse, France, 31052
CHU de Rangueil
Toulouse, France, 31059
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

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01127295     History of Changes
Other Study ID Numbers: 09 SEIN 09
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Institut Claudius Regaud:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents