A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
Phase 4
N/A
N/A
N/A
N/A
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess for serious adverse events
Outcome Time Frame:
Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Belgium: Directorate General for Medicinal product FPS of Public Health, Food Chain Security and Env
Study ID:
A5991077
NCT ID:
NCT00649090
Start Date:
March 2005
Completion Date:
April 2007
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
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