Comparative study of oestradiol suppression: Zoladex 10.8mg/3 month vs. 3.6mg/month in ER +ve EBC pre-menopausal patients
Study identifier:D8664C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Randomized, Parallel Group, Multicentre Study to compare Oestradiol Suppression between ZOLADEX 10.8 mg depot given 3 monthly and ZOLADEX 3.6 mg depot given monthly in Pre-menopausal Patients with ER positive Early Breast Cancer
Medical condition
Breast Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Goserelin acetate
Sex
Female
Actual Enrollment
170
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Feb 2006
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Feb 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Zoladex 3-month depot | Drug: Goserelin acetate injection 10.8 mg every 3 months Other Name: Zoladex |
| Experimental: 2 Zoladex 1-month depot | Drug: Goserelin acetate Injection 3.6 mg monthly Other Name: Zoladex |
Contacts
Investigators
Principal Investigator
AstraZeneca Japan Medical Director
AstraZeneca
