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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00266799 | The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071) | PHASE3 | COMPLETED | 210 | — | — | Jan 13, 2006 | Oct 18, 2010 | Jun 8, 2017 | - | — |
TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ \& \>20 mm by clinical imaging (\>=10 mm with spiral CT scan). Non-target lesions were all other lesions.
| Arm | Type | Description |
|---|---|---|
| Pegylated liposomal doxorubicin | EXPERIMENTAL | - |
| Capecitabine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pegylated liposomal doxorubicin (SCH 200746) | DRUG | pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity |
| Capecitabine | DRUG | capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity |
Inclusion Criteria: * Patients must be female. * Patients must have metastatic disease of a cytological or histological confirmed breast cancer. * Patients must be 18 years or older. * Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST crite...