Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lapatinib · 1 trial · 2 indications
Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Chemotherapy | EXPERIMENTAL | Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year. |
| Name | Type | Description |
|---|---|---|
| Lapatinib | DRUG | 1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles) |
| Doxorubicin | DRUG | 60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide. |
| Cyclophosphamide | DRUG | 600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin. |
| Docetaxel | DRUG | 100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide |
| Pegfilgrastim | DRUG | 6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments. |
| Filgrastim | DRUG | 300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies. |
| Dexamethasone | DRUG | 8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel |
| Trastuzumab | DRUG | Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year |
INCLUSION CRITERIA * Female * Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+ * Stage II/III breast cancer including any large primary tumor (\> 2 cm), tumors of any size associated with skin or chest wal...
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