SWOG clinical trial number
S9626
A Phase III Trial of Placebo Versus Megestrol Acetate 20 mg/Day Versus Megestrol Acetate 40 mg/Day as Treatment for Symptoms of Ovarian Failure in Women Treated for Breast Cancer
Closed
Phase
Accrual
100%
Published
Treatment
Megestrol acetate
Eligibility Criteria Expand/Collapse
Stage T1-3, N0-1, M0 infiltrating breast cancer treated with appropriate local and regional therapy; pts w/DCIS are not eligible; ¤pts must have completed all primary therapy for breast cancer; pts taking tamoxifen must have started tamoxifen >= 4 months prior to randomization; pts must have never participated in any NCI sponsored adjuvant breast protocols; pts must have completed Patient Daily Log of Hot Flashes for 7 days prior to
randomization and must have recorded 10 or more hot flashes of any severity or 5 or more severe or very severe hot flashes; pt must not be pregnant; pts must not currently be on steroids or any other hormones except tamoxifen.
randomization and must have recorded 10 or more hot flashes of any severity or 5 or more severe or very severe hot flashes; pt must not be pregnant; pts must not currently be on steroids or any other hormones except tamoxifen.
Publication Information Expand/Collapse
2008
A phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group study 9626 [PMID18375894 ]
2001
Double blind phase III trial of placebo (P) vs. megestrol acetate (MA) 20 mg vs. MA 40 mg as treatment for symptoms of ovarian failure in breast cancer survivors: Initial results of Southwest Oncology Group S9626