Among postmenopausal women with advanced, estrogen receptor-positive breast cancer that has progressed or recurred after prior hormonal therapy, a higher dose of Faslodex® (fulvestrant) appears to be more effective than the standard dose. These results were presented at the 2009 San Antonio Breast Cancer Symposium.
Faslodex is a type of hormonal therapy known as an antiestrogen. It’s used for the treatment of metastatic, hormone receptor-positive breast cancer in postmenopausal women who experience cancer progression or recurrence after prior hormone therapy. A standard dose of Faslodex is 250 mg per month.
In order to assess the effects of a higher dose of Faslodex, researchers conducted a Phase III clinical trial known as CONFIRM (Comparison of Faslodex in Recurrent or Metastatic breast cancer). The study compared the standard dose of Faslodex to a higher dose (500 mg) among 736 women in 17 countries.
- Compared with the lower dose, the higher dose of Faslodex delayed cancer progression. Median time to cancer progression was 6.5 months among patients treated with the 500 mg dose and 5.5 months among patients treated with the 250 mg dose.
- No new safety concerns were identified with the 500 mg dose. The most common side effects included nausea, bone pain, back pain, and injection site pain.
The results of the study suggested that a higher dose of Faslodex may be more active than the standard dose, and as well tolerated.
Reference: Di Leo A. CONFIRM: A Phase III, Randomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500 mg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast Cancer. Presented at the 32nd CTRC-AACR San Antonio Breast Cancer Symposium. December 9-13, 2009. San Antonio, TX. Abstract 25.