Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Patients with operable breast cancers will receive orally treatment with anastrozole (1 mg/day), tamoxifen (20 mg/day) or placebo during 26 days.
Sponsors
Federal University of Sao Paulo (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Histologically confirmed invasive breast cancer in women who were postmenopausal, which is defined as no menstruation periods over the last 12 months and/or an FSH level within the postmenopausal range.
Exclusion criteria
Exclusion criteria: 1. The presence of endocrine disease, metastatic disease, inflammatory breast cancer (T4d) 2. History of thromboembolism 3. Use of hormone replacement therapy (HRT) or previous treatment for breast cancer (surgery, radio or chemotherapy). Patients who do not comply with the prescribed medication regimen or postpone surgery are also excluded from the study. Patients who had previously taken HRT may be included if they have stopped hormonal treatment at least six months prior to trial randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the role of ER-ß in predicting the response to breast cancer therapy with anastrozole and tamoxifen we will observe the expression of Ki67 (cell proliferation marker) in tumor biopsy samples taken before and after treatment (26 days) of ER-ß-positive and ER-ß-negative breast cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The ER-a/ER-ß expression ratio predicting the response to breast cancer endocrine therapy and whether different regimens of treatment have any effect on ER-a and ER-ß expression levels. | — |
Countries
Brazil
Outcome results
None listed