A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Phase 3
45 Years
N/A
45 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Inclusion Criteria:
- Eligible for entry into the main ATAC trial 1033IL/0029
- Patients must have been taking ATAC trial medication for at least 3 months (i.e.
patients must have reached at least visit 2 of the main ATAC study)
- Patients should be taking their medication in the mornings for at least 3 months
- Patients must be 100% compliant over the preceding fourteen days
Exclusion Criteria:
- Excluded from entry into the main ATAC trial (1033IL/0029)
- Patients whose concurrent treatment includes diazepam or drugs which might affect
tamoxifen steady state levels or steroid hormone status. These include ketoconazole
(antifungal) or related compounds
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Steady state plasma trough concentrations of tamoxifen, desmethyltamoxifen and anastrozole
Outcome Time Frame:
24±4 hours after previous dose
Safety Issue:
Yes
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
1033IA/0029
NCT ID:
NCT00784862
Start Date:
June 1998
Completion Date:
March 1999
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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