Conditions: Advanced Breast Cancer
Keywords: oncology cancer breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks arm 2: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks

Interventions: intervention 1: Goserelin acetate intervention 2: Goserelin acetate
Intervention descriptions: intervention 1: 3.6 mg intramuscular depot injection given every 4 weeks intervention 2: 10.8 mg intramuscular depot injection given every 12 weeks

Protocol document: