A Phase 2 interventional study of Goserelin acetate and Goserelin acetate in Breast Cancer, sponsored by AstraZeneca. Completed at 22 sites in Japan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2009-12-23.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 170 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Zoladex 3-month depot
Drug: Goserelin acetate
Zoladex 1-month depot
Drug: Goserelin acetate
Injection 3.6 mg monthly
Also known as: Zoladex
injection 10.8 mg every 3 months
Also known as: Zoladex
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
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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