Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Zoladex EBC Study |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Zoladex 3-month depot |
|
| 2 | Experimental | Zoladex 1-month depot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin acetate | Drug | Injection 3.6 mg monthly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Japan Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chiba | Japan | ||||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Goserelin acetate | Drug | injection 10.8 mg every 3 months |
|
|
| Fukuoka |
| Japan |
| Research Site | Fukushima | Japan |
| 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 |
| Research Site | Miyazaki | Japan |
| Research Site | Nagoya | Japan |
| Research Site | Niigata | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōta-ku | Japan |
| Research Site | Saitama | Japan |
| Research Site | Sayama | Japan |
| Research Site | Shimotsuke | Japan |
| Research Site | Suita | Japan |
| Research Site | Tokorozawa | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Utsunomiya | Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided