At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating ZD9393 (Zoladex) 10.8 mg and ZD9393 (Zoladex) 3.6 mg for Breast Cancer. Completed, enrolled 222 participants across 55 sites in 6 countries.
Detailed Summary
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.
Study Details
Timeline
Interventions
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).