Pharmacology of Adjuvant Hormonotherapy in Breast Cancer (PHACS)
This study is currently recruiting participants.
Verified November 2011 by Institut Claudius Regaud
Sponsor:
Institut Claudius Regaud
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
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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:
- Patient of more than 18 years old (menopaused or not)
- Invasive breast cancer non-metastatic locally controlled by surgery with or without radiotherapy. Previous treatment with chemotherapy is allowed including trastuzumab
- Cancer hormone-expressing ER and / or PR (> 10% tumor cells in Technical HIC)
- Having a staging exploring bone, liver, lung and showing no abnormality secondary (for sub-centimeter tumors, the staging is not necessary)
- WHO <2
- 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)
- signed Consent collected before any specific procedure in the study
- Patient member in a national insurance scheme.
Exclusion Criteria:
- Patient previously treated for breast cancer receiving hormonal therapy with tamoxifen, anastrozole, letrozole or exemestane regardless of the scheme
- Metastatic Breast cancer
- 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)
- 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
- Patient unable to follow procedures, visits, examinations described in the study
- Pregnant women or nursing mothers can not participate in the study
- Women of childbearing age must use effective contraception at study entry and up to at least three months after the end of treatment
- Patient under legal guardianship
Contacts and Locations
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 Adjuvants, Immunologic Tamoxifen Anastrozole Exemestane Letrozole Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013