study of Zoladex given every 12 weeks versus given every month in Advanced Breast Cancer (ABC) pre-menopausal women
Study identifier:D8664C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX 10.8 mg Given Every 12 Weeks with ZOLADEX 3.6 mg Given every 4 Weeks in Pre-menopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer
Medical condition
Advanced breast cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Goserelin acetate
Sex
Female
Actual Enrollment
98
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2006
Primary Completion Date: -
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZOLADEX 10.8 mg ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks | Drug: Goserelin acetate 10.8 mg intramuscular depot injection given every 12 weeks Other Name: Zoladex® |
| Experimental: ZOLADEX 3.6 mg ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks | Drug: Goserelin acetate 3.6 mg intramuscular depot injection given every 4 weeks Other Name: Zoladex® |
Contacts
Investigators
Principal Investigator
Breast Cancer Established Brands Team Medical Science Director
AstraZeneca
