05/27/2002 By Anne MacLennan
Further clinical development of droloxifene has been stopped as a result of a multicentre international trial of comparing the drug with tamoxifen as first-line treatment for advanced breast cancer.
Droloxifene was significantly less effective overall than was tamoxifen in both pre- and post-menopausal women with ER+ and/or PgR+ advanced breast cancer in this randomised trial, and particularly in women under 65 years.
Both drugs proved to be less effective in pre-menopausal women with receptor-positive disease than in post-menopausal women. The study, done by A Buzdar and colleagues from The University of Texas, Anderson Cancer Center, Houston, Texas with others from around the world, was designed to demonstrate equivalence between droloxifene 40 mg/d and tamoxifen 20 mg/d as first-line treatment based on time to disease progression and tumour response. The 1,354 women participating were from 179 institutions in 35 countries; all had measurable disease previously untreated by hormonal or chemotherapy for advanced or recurrent breast cancer.
The patients were stratified at baseline for menopausal status, randomised to 40 mg droloxifene or 20 mg tamoxifen daily as single-agent therapy, and underwent tumour assessment every three months.
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