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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00524303 | Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy. | PHASE2 | COMPLETED | 100 | — | — | Aug 1, 2007 | Aug 1, 2015 | Nov 11, 2016 | 23 | United States |
A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ \[DCIS\] or lobular carcinoma in situ \[LCIS\] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery |
| Arm 2 | EXPERIMENTAL | Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery |
| Arm 3 | EXPERIMENTAL | Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | 4mg/kg IV loading dose followed by 2mg/kg IV weekly |
| Paclitaxel | DRUG | 80mg/m2 IV weekly for 4 (21 day) cycles |
| FEC75 | DRUG | 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles |
| Lapatinib | DRUG | 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3 |
Inclusion Criteria: * Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA). * Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2). * ErbB2 overexpressing breast cancer, defined as one of the following de...