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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00820222 | Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer | PHASE3 | COMPLETED | 540 | — | — | Apr 14, 2009 | Mar 22, 2018 | Apr 2, 2019 | 164 | United States, Belgium +12 |
CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a \<6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.
| Arm | Type | Description |
|---|---|---|
| Lapatinib plus capecitabine | EXPERIMENTAL | Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days |
| Trastuzumab plus capecitabine | ACTIVE_COMPARATOR | trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days |
| Name | Type | Description |
|---|---|---|
| capecitabine | DRUG | oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle |
| lapatinib | DRUG | oral medication; daily dose taken once a day |
| trastuzumab | DRUG | infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks |
Inclusion Criteria: * Females at least 18 years old; * ECOG Performance Status 0-2; * Histologically or cytologically confirmed HER2-positive invasive breast cancer, with Stage IV disease; * Prior treatment with taxanes or anthracyclines is required; * Prior treatment with other chemotherapeutic ag...