A multi-center phase II study of three doses of TAS-108 in postmenopausal women with advanced breast carcinoma following first or second line endocrine therapy.

Abstract:

Abstract #2131 Introduction: TAS-108 is an oral steroidal anti-estrogen agent that selectively inhibits ERα and is mainly metabolized by CYP3A4. The purpose of this study is to investigate the efficacy and safety of TAS-108 administrated orally in three dose levels in patients with locally advanced, locally recurrent inoperable or metastatic breast carcinoma (BC) in four countries (USA, Russia, Mexico and Chile). Methods: Postmenopausal women with confirmed ER and/or PgR positive BC who had previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy were randomly assigned to three doses of TAS-108, 40 mg, 80 and 120 mg daily. Using a modified Panageas' optimal two-stage trinomial design, the enrollment of 60 evaluable patients (first-stage: 19) was required to each individual dose group. Tumor response was assessed every 8 weeks …

Año de publicación:

2009

Keywords:

Fuente:

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