Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors
- 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
- 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.
- 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
- 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
- Patients under law protection