CSPOR

SELECT BC

A Randomized study comparing taxanes with TS-1 in patients with metastatic or recurrent breast cancer

Study design

This is a multicenter, collaborative, open-label, randomized, parallel-group, controlled study.

Trial Schema

Objectives

1. To verify that TS-1 is at least equivalent (non-inferior) to a taxane with respect to overall survival in patients with metastatic or recurrent breast cancer who receive either a taxane or TS-1 as first-line treatment, followed by second-line and subsequent therapy at the physician’s discretion. Progression-free survival and time to treatment failure will also be compared between the treatment groups.
2. Adverse events, HRQOL, and medical economic evaluation will be compared between the treatment groups.

Primary endpoint: Overall survival (OS)

Secondary endpoints: Progression-free survival (PFS), time to treatment failure (TTF), adverse events, HRQOL, and medical economic evaluation

Scheduled number of patients and study period

Planned sample size: A total of 600 patients (300 per group).
Enrollment period: from October 2006 through July 2010.
Follow-up: 3 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN C000000416

Medical papers

Study design: Jpn J Clin Oncol 40:811-814, 2010

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