| March 16, 2006 |
| June 18, 2009 |
| February 2006 |
| August 2007 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00303524 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: No ] |
| 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. |
| |
| Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-Menopausal Patients |
| An Open-Label, Randomized, Parallel Group, Multicentre Study to Compare Oestradiol Suppression Between ZOLADEX 10.8 mg Depot Given 3 Monthly and ZOLADEX 3.6 mg Depot Given Monthly in Pre-Menopausal Patients With ER Positive Early Breast Cancer |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Breast Cancer |
| Drug: Goserelin acetate |
- Experimental: Zoladex 3-month depot
- Experimental: Zoladex 1-month depot
|
| |
| |
| Active, not recruiting |
| 170 |
| February 2009 |
| August 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.
Exclusion Criteria:
- Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy
|
| Female |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00303524 |
|
| D8664C00004, Zoladex EBC Study |
| AstraZeneca |
|
| Study Director: |
AstraZeneca Japan Medical Director, MD |
AstraZeneca |
|
|
| AstraZeneca |
| June 2009 |
