Study to Compare Zoladex™ 10.8 mg with Zoladex 3.6 mg in Pre-menopausal Women with Breast Cancer
Study identifier:D8666C00001
ClinicalTrials.gov identifier:NCT01073865
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
Breast Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
ZD9393 (Zoladex) 10.8 mg, ZD9393 (Zoladex) 3.6 mg
Sex
Female
Actual Enrollment
222
Study type
Interventional
Age
20 Years - 130 Years
Date
Study Start Date: 26 Feb 2010
Primary Completion Date: 19 Sept 2012
Study Completion Date: 20 Nov 2017
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days). One oral tamoxifen 20 mg tablet also will be taken daily | Drug: ZD9393 (Zoladex) 10.8 mg 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days). Other Name: Zoladex |
| Active Comparator: 2 Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily. | Drug: ZD9393 (Zoladex) 3.6 mg 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days). Other Name: Zoladex |
Contacts
Investigators
Principal Investigator
Justin Lindemann
AstraZeneca
