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Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Hormono-depending Adjuvant Breast Cancer

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Trial Information

Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Correlation between pharmacokinetic and pharmacogenetic parameters

Outcome Description:

To estimate the correlations between pharmacokinetic and pharmacogenetic parameters of hormonal adjuvant breast cancer treatment during the first 3 years.

Outcome Time Frame:

9 years

Safety Issue:

No

Principal Investigator

Henri ROCHE, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

09 SEIN 09

NCT ID:

NCT01127295

Start Date:

May 2010

Completion Date:

May 2016

Related Keywords:

  • Hormono-depending Adjuvant Breast Cancer
  • Pharmacokinetics
  • Pharmacogenetic
  • tamoxifen
  • anti-aromatases
  • breast cancer
  • pharmacodynamy
  • Observance
  • Breast Neoplasms

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