Jornal de Ensaios Clínicos
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Estudo randomizado de dose ideal, estudo de fase II de NabPaclitaxel trissemanal em doentes com cancro da mama metastático (ABROAD)

Fumikata Hara, Tsutomu Takashima, Junji Tsurutani, Tsuyoshi Saito, Naruto Taira, Kosuke Kashiwabara, Tomohiko Aihara, Hirofumi Muka

hNab-paclitaxel (nab-PTX) is a paclitaxel albumin-stabilized nanoparticle formulation. Nab-PTX has demonstrated superiority over conventional PTX in terms of objective response rate (ORR) and progression free survival in metastatic breast cancer. However chemotherapy induced grade 3 or higher peripheral neuropathy (CIPN) was more frequently observed in nab-PTX. More recent phase 3 study CALGB 40502 could not prove superiority of weekly nab-PTX to weekly PTX because of higher incidence of toxicity by standard dose of nab-PTX. Taken together, there is a room for the further study to find the optimal dose of nab-PTX. In a single arm phase 2 study CA002-0LD, low dose tri-weekly nab-PTX 175 mg/m2 showed good ORR (39.5%) and no CIPN of grade 3 or higher. Thus we conducted randomized phase 2 study (ABROAD) for optimal dose finding of nab-PTX, comparing three different dose of tri-weekly nab-PTX (180 mg/m2 vs. 220 mg/m2 vs. 260 mg/m2 ) in patients with metastatic breast cancer.