A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study.

ABSTRACT:

Purpose

The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC).

Methods

This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m² doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m² every 28 days or capecitabine 1250 mg/m² twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP).

Results

210 patients were randomized (n = 105, PLD and n = 105, capecitabine

SUBMITTER: Harbeck N 

PROVIDER: S-EPMC5222915 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature