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 2 clinical trial evaluating Goserelin acetate for Advanced Breast Cancer. Completed, enrolled 98 participants across 14 sites in 3 countries.
Detailed Summary
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks. Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years
Study Details
Timeline
Interventions
3.6 mg intramuscular depot injection given every 4 weeks
10.8 mg intramuscular depot injection given every 12 weeks