Control Group: Women without hormone replacement therapy. Transvaginal Ultrasound - Endometrial Thickness; Endometrial Biopsy. Endometrial Immunohistochemical Study

Group Drospirenone: To whom a continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg (DRSP/E2) will be administered daily for 24 weeks.
Group Tibolone: To whom treatment with tibolone 1.25 mg (Tib) will be administered daily for 24 weeks.
Transvaginal Ultrasound - Endometrial Thickness; Endometrial Biopsy. Endometrial Immunohistochemical Study

Menopause

Endometrial Biopsy

Transvaginal Ultrasound

Immunoexpression of estrogen (ER) and progesterone receptors (PR) and Bcl-2 protein

Endometrial Immunohistochemical

Vale Do Sapucai University (Univas)

Hormone Replacement Therapy on the Postmenopausal Endometrium

Comparative Effects of Drospirenone and Tibolone on the Postmenopausal Endometrium

Transvaginal ultrasound will be performed to evaluate the thickness of the endometrium in milimiters at baseline and the end of the study in postmenopausal women under use of drospirenone and tibolone. The results will be expressed as mean and standard deviation.

Histological and immunohistochemical detection of Bcl-2 protein will be performed on postmenopausal endometrium. The cell count will be expressed as numerical density, i.e. number of positive cells per square millimeter of epithelium.

The presence of estrogen and progestogen receptors will be performed on postmenopausal endometrium. The cell count will be expressed as numerical density, i.e. number of positive cells per square millimeter of epithelium.

Benedito Fabiano dos Reis

Professor

Universidade do Vale do Sapucai

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.

Tarceva

Sex: Female, Male

Region of Enrollment

In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.

Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.

Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva

Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining

Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.

Molecular Profile of Participants Who Are Responsive to Tarceva

Post-treatment plasma level in µmol/L of erlotinib hydrochloride

Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.

Average Post-treatment Plasma Level of Erlotinib Hydrochloride

Overall Study

Carlos Arteaga, M.D.

Breast Cancer

Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.

erlotinib hydrochloride

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

TUNEL assay

protein expression analysis

immunohistochemistry staining method

Used to assess level of expression of genetic markers in pre-therapy and surgical specimens

laboratory biomarker analysis

Used to determine blood plasma levels of Erlotinib on the day of surgery

liquid chromatography

mass spectrometry

After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue

matrix-assisted laser desorption ionization mass spectrometry

Surgical treatment will occur within 24-hours following completion of therapy.

therapeutic conventional surgery

University of Alabama, Birmingham

Dana-Farber Cancer Institute

Lineberger Comprehensive Cancer Center

Meharry Medical College

Vanderbilt-Ingram Cancer Center

Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer

biotin/cancer du sein

Hormone Replacement Therapy on the Postmenopausal Endometrium

Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

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