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: SWOG Study S9626
OBJECTIVES: I. Compare the effectiveness and duration of the benefit of placebo versus low
dose megestrol versus high dose megestrol in the reduction of severe and/or frequent hot
flashes in patients with previously treated invasive breast cancer. II. Document the effects
of various dose levels of megestrol on atrophic vaginitis and dyspareunia in these patients.
III. Evaluate the toxicity of this treatment in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to tamoxifen use (yes vs no), number of hot flashes per week (5-34
vs 35-63 vs more than 63), and duration of hot flashes (6 months or less vs longer than 6
months). Patients are randomized to one of three treatment arms. Arm I: Patients receive
oral placebo daily. Arm II: Patients receive lower dose oral megestrol daily. Arm III:
Patients receive higher dose oral megestrol daily. Patients who do not respond after 3
months of treatment receive an additional dose of oral megestrol daily. Treatment continues
for a total of 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months.
PROJECTED ACCRUAL: A total of 279 eligible patients (93 per arm) are expected to be accrued.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Effectiveness and duration of the benefit of placebo and 2 dose levels of megestrol acetate in reduction of severe and/or frequent hot flashes in patients with history of adequate local and regional treatment of invasive breast cancer
3, 6, and 9 months
John W. Goodwin, MD
Cancer Research for the Ozarks
United States: Federal Government