alexa Randomized, Optimal Dose Finding, Phase Ii Study of Tri-Weekly NabPaclitaxel in Patients with Metastatic Breast Cancer (ABROAD)
ISSN: 2167-0870

Journal of Clinical Trials
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Protocol

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

Fumikata Hara1*, Tsutomu Takashima2, Junji Tsurutani3, Tsuyoshi Saito4, Naruto Taira5, Kosuke Kashiwabara6, Tomohiko Aihara7, and Hirofumi Mukai8

1National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

2Osaka City University Graduate School of Medicine, Osaka, Japan

3Kinki University Faculty of Medicine, Osakasayama, Japan

4Saitama Red Cross Hospital, Saitama, Japan

5Okayama University Hospital, Okayama, Japan

6University of Tokyo, Tokyo, Japan

7Aihara Hospital, Minoh, Japan

8National Cancer Center Hospital East, Kashiwa, Japan

*Corresponding Author:
Fumikata Hara
Department of Breast Oncology
National Hospital Organization Shikoku Cancer Center
160 Ko Minaamiumemoto, Matsuyma
Ehime, 791-0280, Japan
Tel: +81-89-999-1111
E-mail: [email protected]

Received Date: January 09, 2016; Accepted Date: April 06, 2016; Published Date: April 11, 2016

Citation: Hara F, Takashima T, Tsurutani J, Saito T, Taira N, et al. (2016) Randomized, Optimal Dose Finding, Phase Ii Study of Tri-Weekly Nab-Paclitaxel in Patients with Metastatic Breast Cancer (ABROAD). J Clin Trials 6:267. doi:10.4172/2167-0870.1000267

Copyright: © 2016 Hara F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Abstract

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.

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