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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00091442 | A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer | PHASE3 | COMPLETED | 751 | — | — | Sep 1, 2004 | Dec 1, 2008 | Apr 21, 2014 | 147 | United States, Bulgaria +16 |
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| DOXIL and docetaxel combination therapy | EXPERIMENTAL | DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. |
| Docetaxel monotherapy | ACTIVE_COMPARATOR | Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
| DOXIL | DRUG | DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. |
Inclusion Criteria: * Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study * Participant...