Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
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