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ZD9393 · 1 trial · 1 indication
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...
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ZD9393 is being developed for the treatment of breast cancer in pre-menopausal women. It is a small molecule studied in a Phase 3 trial comparing the 10.8 mg dose with the 3.6 mg dose in this patient population. The trial enrolled 222 female participants aged 20 years and older.
ZD9393 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 3 study evaluating the drug in pre-menopausal women with breast cancer across sites in India, Japan, the Philippines, South Korea, Taiwan, and Thailand.
ZD9393 is in Phase 3 development. The single registered trial, NCT01073865, has completed, and no active trials are currently listed. The study was randomized, active-controlled, and enrolled 222 participants. ZD9393 is investigational and is not described as approved.
ZD9393 was evaluated in the Phase 3 trial NCT01073865, titled a study to compare Zoladex 10.8 mg with Zoladex 3.6 mg in pre-menopausal women with breast cancer. The trial is completed, enrolled 222 participants, used an active-controlled randomized design, and was conducted in six countries across Asia.