Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

Study Overview
=================
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 tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.

Official Title
-----------------
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

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Exemestane
* Drug: tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exemestane|25mg a day during 4 months|
|Drug: tamoxifen|One 20 mg tablet a day started 1 week after the first Aromasine intake|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the objective response rate (complete response and partial response) |  | June 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic interaction between Exemestane and Tamoxifen |  | june 2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, locally advanced, Menopausal patient, aromasin, tamoxifen, efficacy