Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study).

ABSTRACT:

Background

Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer.

Methods

This multicenter, phase II study using a Simon's two-stage design investigated the efficacy and safety of DHP107 200 mg/m² administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer.

Results

Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34-81) and 11 (31%) had triple-negati

SUBMITTER: Kim SB 

PROVIDER: S-EPMC8679020 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature