Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01073865 | Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer | PHASE3 | COMPLETED | 222 | — | — | Feb 26, 2010 | Nov 20, 2017 | Dec 12, 2018 | 55 | India, Japan +4 |
A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 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 |
| 2 | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| ZD9393 (Zoladex) 10.8 mg | DRUG | 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days). |
| ZD9393 (Zoladex) 3.6 mg | DRUG | 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days). |
Inclusion Criteria: * Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation. * Hormone sensitivity (ER positive) of primary or secondary tumour tissue. * Histological/cytol...