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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00550771 | Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048) | PHASE2 | COMPLETED | 181 | — | — | Jul 16, 2007 | Aug 23, 2010 | Jun 7, 2017 | - | — |
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
| Arm | Type | Description |
|---|---|---|
| Doxorubicin Based Regimen | ACTIVE_COMPARATOR | - |
| Pegylated Liposomal Doxorubicin (PLD) Based Regimen | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| doxorubicin, cyclophosphamide, paclitaxel, trastuzumab | DRUG | doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses) |
| PLD, cyclophosphamide, trastuzumab, paclitaxel | DRUG | PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses) |
Inclusion Criteria: * Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria. * Subjects must demonstrate willingness to and be able to participate in the study and to...