European early phase II dose-finding study of droloxifene in advanced breast cancer.

摘要: Preliminary results from clinical phase II studies with droloxifene demonstrated efficacy and good tolerability. One hundred ninety-six female, postmenopausal patients advanced breast cancer were treated 20, 40, or 100 mg of daily. Exclusion criteria as follows: negative ER/PR status, tamoxifen treatment within the preceding three months, chemotherapy weeks, performance grade four. Seventeen percent 20 daily responded to treatment, exhibiting complete partial responses according World Health Organization criteria. In 40-mg group, 30% in 100-mg 31% responded. Adverse symptoms generally mild.