The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Injection 3.6 mg monthly
injection 10.8 mg every 3 months
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment.
Time frame: every 12 weeks
Zoladex 10.8mg has similar safety and tolerability profile to Zoladex 3.6mg. Examination of goserelin pharmacokinetics (PK) in Japanese patients after injection of Zoladex 10.8mg. Efficacy of Zoladex 10.8mg is similar to 3.6mg by assessment of DFS.
Time frame: every 12 weeks
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Research Site
Isehara, Japan
Research Site
Kagoshima, Japan
Research Site
Kashiwa, Japan
Research Site
Kawasaki, Japan
Research Site
Kitakyushu, Japan
Research Site
Kumamoto, Japan
Research Site
Matsuyama, Japan
...and 12 more locations