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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 an investigational small molecule being developed for the treatment of breast cancer. It is currently in Phase 3 clinical development. The drug is being studied in pre-menopausal women with breast cancer, as part of a randomized, active-controlled trial.
ZD9393 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with breast cancer.
ZD9393 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial for the treatment of breast cancer.
ZD9393 has been studied in one clinical trial, identified as NCT01073865. This was a Phase 3, randomized, active-controlled study that compared ZD9393 with another treatment in pre-menopausal women with breast cancer. The trial was completed and enrolled 222 participants.
ZD9393 is being studied in a clinical trial that compares it to Zoladex, but it is not stated to be the same as Zoladex. The trial, NCT01073865, is titled 'Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer.'