Estrogen Receptor Beta (ER-ß) as a coadjuvant target of neoadjuvant endocrine therapy

Completed

Conditions: Breast Cancer
Cancer
Malignant neoplasm of breast

Registration Number: ISRCTN89801719

Lead Sponsor: Federal University of Sao Paulo (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 90

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.