NIPH Clinical Trials Search

A study on the effect of improving the QOL (quality of life), response and safety of eribulin mesylate for inoperable or recurrent breast cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	inoperable or recurrent breast cancer
Date of first enrollment	2011/08/20
Target sample size	100
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	eriburin mesylate 1.4mg/m2, days 1 and 8, q21 days.

Outcome(s)

Primary Outcome	The effect of improving the QOL(Quality of life) evaluated by the FACT-B
Secondary Outcome	- OSS (objective response rate) evaluate by RECIST - Safety

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	- patients with advanced bone marrow suppression. - patients who has an anamnesis of hypersensitivity to the ingredient of this agent. - pregnant women or the women that may have become pregnant - patients simultaneously treatmented by trastuzumab or lapatinib. - patients who judged that it was unsuitable as other candidates