Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study.

ABSTRACT:

Background

Eribulin is a nontaxane microtubule inhibitor with activity in patients with metastatic breast cancer (MBC). We conducted a phase I dose-finding study of eribulin and capecitabine in patients with MBC pretreated with anthracycline and taxane.

Methods

Women with MBC aged ≤70 years were enrolled. A 3 + 3 dose escalation design was used: level 0 dosing, eribulin (1.4 mg/m² intravenously on days 1 and 8) plus capecitabine [825 mg/m² orally twice daily (BID)]; 2-weeks-on, 1-week-off in a 21-day cycle. If there were no dose-limiting toxicities (DLTs), level 1 capecitabine dose was 1000 mg/m² BID. The primary objective was to determine maximum tolerated dose, DLTs, and recommended dose (RD). Secondary objectives included pharmacokinetics,

SUBMITTER: Hattori M 

PROVIDER: S-EPMC5741785 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature