ATAC - Pharmacokinetics (PK) Sub-protocol
Study identifier:1033IA/0029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Breast Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Anastrozole, Tamoxifen
Sex
Female
Actual Enrollment
9358
Study type
Interventional
Age
45 Years +
Date
Study Start Date: 01 Jun 1998
Primary Completion Date: -
Study Completion Date: 01 Mar 1999
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Arimidex 1mg + Nolvadex placebo | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex |
| Active Comparator: 2 Arimidex placebo + Nolvadex 20mg | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
| Active Comparator: 3 Arimidex 1mg + Nolvadex 20mg | Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
