Status:
COMPLETED
Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant
Lead Sponsor:
Institut Claudius Regaud
Collaborating Sponsors:
PHARMACIA SAS
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
60+ years
Phase:
PHASE2
Brief Summary
This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxi...
Eligibility Criteria
Inclusion
- Breast cancer histologically proven by a 14 G or 16 G micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors.
- Menopausal patients as defined as follows:
- Natural menopause \>= 1 year, or
- Surgical ovariectomy.
- T unilateral tumor\> 3 cm, N 1-2, M0 or M +, non-inflammatory.
- Hormone receptor positive. RE positive or PR positive with histochemical technique (+ 10% of cells express the receptor)
- No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. Discontinuation of replacement therapy of menopause for at least 1 month
- Age\>= 60 years
- Evaluable disease
- Performance Status \<= 2
- Biological function using the following criteria:
- neutrophils \>= 2.10E9 / l,
- Platelets\> = 100.10E9 / l,
- Hemoglobin\> = 10 g / dl,
- Creatinine \<= 1.5 x upper normal,
- Total bilirubin \<= 1.25 x the upper normal
- Transaminases (AST and ALT) \<= 1.5 x upper normal,
- Alkaline phosphatase \<= 2.5 x upper normal.
- Cardiac Function: electrocardiogram (ECG) normal.
- Signed written consent before any procedure related to the study.
Exclusion
- Men
- Non Menopausal Patients
- Patients with hormone receptor negative: PR- and RE -
- Contra-indication to anti-estrogens (risk thrombi arteria)
- Tumor \<3 cm operable
- Tumor inflammatory T4d (PEV 2 or 3).
- Extensive hepatic lesions (\> 1 / 3 of liver volume)
- Uncontrolled cardiac disease such as angina, congestive heart failure, or arrhythmia requiring medical treatment or history of myocardial infarction within 3 months before.
- History of cancer except skin cancer and basal cell cancer in situ of the cervix (a contralateral breast cancer had been no systemic treatment will be admitted).
- Chronic diseases (somatic or psychiatric) in poor prognosis.
- Patients who for reasons of family, social, geographical or psychological can not be followed properly.
- Patients under law protection
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00919399
Start Date
January 1 2002
End Date
June 1 2006
Last Update
June 12 2009
Active Locations (2)
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1
CHU de Toulouse Rangueil
Toulouse, France
2
Institut Claudius Regaud
Toulouse, France