Conditions: Breast Cancer
Keywords: ZOLADEX Pre-menopausal Oestrogen Receptor Advanced Breast Cancer Progression Free Survival
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 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 arm 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.

Interventions: intervention 1: ZD9393 (Zoladex) 10.8 mg intervention 2: ZD9393 (Zoladex) 3.6 mg
Intervention descriptions: intervention 1: 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days). intervention 2: 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Protocol document: