Abstract
645 Background: 667-Coumate is the first steroid sulfatase (STS) inhibitor to enter clinical trials. STS has a crucial role in regulating the formation of steroids with potent estrogenic properties, such as estrone and androstenediol. Methods: Eligible patients (pts) are postmenopausal women with locally advanced or metastatic hormone receptor positive breast cancer. Treatment consists of a test dose followed by 3 two-weekly cycles. Each cycle consists of daily dosing for 5 days followed by 9 days off treatment. Dose levels of 5mg, 20mg and 80mg (6 pts at each) were planned. Primary endpoints are to establish the oral dose of 667-Coumate needed to suppress STS by over 90% in peripheral blood lymphocytes (PBL) and to investigate the tolerability profile of 667-Coumate. Secondary endpoints include measurement of the pharmacokinetic and endocrine parameters, determination of the oral dose of 667-Coumate needed to inhibit intra-tumoral sulfatase and documentation of anti-tumor activity. PBL STS was measured u...
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