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| Name | Class |
|---|---|
| PHARMACIA SAS | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug | 25mg a day during 4 months |
| |
| tamoxifen | Drug | One 20 mg tablet a day started 1 week after the first Aromasine intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the objective response rate (complete response and partial response) | June 2006 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic interaction between Exemestane and Tamoxifen | june 2006 |
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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:
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:
Cardiac Function: electrocardiogram (ECG) normal.
Signed written consent before any procedure related to the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri ROCHE | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Toulouse Rangueil | Toulouse | France | ||||
| Institut Claudius Regaud |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Toulouse |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |