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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00779129 | A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948) | PHASE2 | COMPLETED | 70 | — | — | Mar 1, 2003 | Aug 1, 2007 | Sep 30, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2 |
| Name | Type | Description |
|---|---|---|
| Pegylated Lyposomal Doxorubicin | DRUG | Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. |
| Cyclophosphamide | DRUG | Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. |
Inclusion Criteria: * Female, aged \>=18 years. * Subject must have histologic diagnosis of breast carcinoma. * Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging. * Subject must have previous anthracyclin-based adjuvant regimen and disease-free statu...