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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00075270 | Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer | PHASE3 | COMPLETED | 580 | — | — | Jan 1, 2004 | Mar 1, 2012 | May 6, 2015 | 177 | United States, Argentina +23 |
| NCT00062686 | GW572016 For Treatment Of Refractory Metastatic Breast Cancer | PHASE2 | COMPLETED | 200 | — | — | Nov 1, 2003 | Feb 1, 2005 | Apr 15, 2015 | 7 | Argentina, France +2 |
| NCT00371488 | GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer | PHASE1 | COMPLETED | 11 | — | — | Apr 6, 2006 | Dec 10, 2007 | Aug 31, 2018 | 2 | Japan |
| NCT00169533 | Rollover Study Of Lapatinib In Cancer Patients | PHASE1 | COMPLETED | 31 | — | — | Aug 19, 2004 | May 5, 2009 | Nov 17, 2017 | 12 | United States, Canada +1 |
Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.
Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.
To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks |
| Arm 2 | PLACEBO_COMPARATOR | Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo |
| GW572016 in combination with trastuzumab | EXPERIMENTAL | Lapatinib: A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible. The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria. Trastuzumab: Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Active Comparator |
| GW572016 (Lapatinib) | DRUG | Oral GW572016 Lapatinib |
| GW572016 | DRUG | - |
| GW572016 oral tablets | DRUG | Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets. |
Inclusion criteria: * Signed Informed Consent * Able to swallow an oral medication * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram * Adequate kidney and liver function * Adequate bone marrow function * Tumor tissue available for testing * Prior adj...