Journal of Clinical Trials
Open Access

Abstract

Randomized, Optimal Dose Finding, Phase Ii Study of Tri-Weekly NabPaclitaxel in Patients with Metastatic Breast Cancer (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.