Regimen 1
Cetuximab (Erbitux) + Oxaliplatin + 5-Fluorouracil (5-FU) + Leucovorin
Regimen 2
Oxaliplatin + 5-Fluorouracil (5-FU) + Leucovorin
Details
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Phase III (begin 12/05, closed 6/09) Europe (France, Belgium, UK, Germany, Spain, UK, Austria, Italy, Denmark, Portugal, and Sweden)
colorectal cancer, advanced (Stage III), resected
Enrollment: 2,566 patients |
Eligible patients are selected based on wt Kras tumor status. |
Epidermal growth factor (EGF) receptor (EGFr, ErbB-1, ErbB1, HEr-1, HEr1)
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Regimen 1
Docetaxel (Taxotere) + Trastuzumab (Herceptin)
Regimen 2
Vinorelbine (Navelbine) + Trastuzumab (Herceptin)
Details
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Phase III (begin 5/05, closed 3/10) USA, Europe (Denmark, Norway, Sweden)
breast cancer, locally advanced or metastatic, HEr2-positive, chemotherapy-naive
Enrollment: 284 patients
Eval Tox: 284 patients (metastatic disease=96%) followed for a median duration of 2.5 years
Eval Resp: 284 patients (metastatic disease=96%) followed for a median duration of 2.5 years |
Protocol ID: HERNATA; NCT00430001
Link to Protocol |
OR: 59.3% in both groups
Median TTP: 15.3 months in the vinorelbine arm and 12.4 months in the docetaxel arm, a nonsignificant difference
1-year: 88% in both arms
OS: 39 months in the vinorelbine arm and 36 months in the docetaxel arm
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