The effect of droloxifene (3-hydroxytamoxifen) given as first-line end
ocrine treatment was evaluated in 39 postmenopausal women with advance
d receptor-positive or receptor-unknown breast cancer. The patients ha
d not received any previous anticancer therapy apart from adjuvant tre
atment. The overall response rate (CR + PR) was 51% (8% CR, 43% PR), 9
5% confidence interval +/- 15.7%. Median time to progression (all pati
ents) was 8 months, the median time to response 2 months, while the me
dian duration of response was 10 months. The drug was well tolerated w
ith no major side effects recorded; 16% of the patients experienced ho
t flushes. The response to droloxifene recorded in the present study i
s in accordance with the response rates to tamoxifen as first-line tre
atment in identical groups of patients.