A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer
- Registration Number
- NCT00649090
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1549
Inclusion Criteria
- Postmenopausal patients
- Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
- Estrogen receptor positive breast cancer patients
- Patients who remain free from disease following treatment with tamoxifen
Exclusion Criteria
- Patients taking other drugs for the adjuvant treatment of breast cancer
- Patients taking hormone replacement therapy
- Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exemestane group exemestane -
- Primary Outcome Measures
Name Time Method Assess for serious adverse events Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
- Secondary Outcome Measures
Name Time Method Safety Surveillance Program Duration of trial
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Yvoir, Belgium