hormone replacement therapy in relieving menopausal symptoms in postmenopausal women with previous stage i or stage ii breast cancer

Conditions: Breast Cancer; Hot Flashes; Menopausal Symptoms; Osteoporosis

Summary: rationale: hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer. purpose: this randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage i or stage ii breast cancer.

objectives: * compare disease-free survival and overall survival of postmenopausal women with prior stage i or ii breast cancer treated with hormone replacement therapy (hrt) vs nonhormonal alternatives to hrt. * compare relief of menopausal symptoms and quality of life of patients treated with these regimens. * compare cardiovascular and osteoporotic events in patients treated with these regimens. outline: this is a randomized, multicenter study. patients are stratified according to participating center, age (\ 2 to \< 5 vs ≥ 5). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral or transdermal hrt comprising estrogen with or without progesterone for at least 2 years. * arm ii: patients are offered advice on nonhormonal hrt alternatives. menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter. patients are followed every 6 months for 3 years and then annually thereafter. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * prior diagnosis of stage i or ii breast cancer * no clinical evidence of recurrence * meets criteria for 1 of the following: * amenorrheic for at least the past 6 months * radiotherapy- or chemically-induced ovarian suppression allowed * prior surgical bilateral oophorectomy * experiencing vasomotor symptoms (i.e., hot flashes or night sweats) with or without vaginal dryness * no undiagnosed postmenopausal bleeding * no ductal carcinoma in situ or lobular carcinoma in situ alone * hormone receptor status: * not specified patient characteristics: age * postmenopausal sex * female menopausal status * postmenopausal performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * no severe, active liver disease with abnormal liver function tests * no acute, intermittent porphyria * fibrinolysis and coagulation normal renal * not specified cardiovascular * no prior deep vein thrombosis * thrombophlebitis or superficial phlebitis alone allowed * no prior retinal vein thrombosis pulmonary * no prior pulmonary embolism other * not pregnant * no prior alcohol, drug, or chemical abuse * no other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * not specified chemotherapy * no concurrent chemotherapy endocrine therapy * more than 3 months since prior oral or transdermal hormone replacement therapy (hrt) * more than 5 years since prior hrt implant * no other concurrent hrt * no concurrent gonadotropin-releasing hormone agonists (e.g., goserelin) if less than 2 years of planned treatment remains * no other concurrent low-dose progestins * no concurrent tibolone * no concurrent phytoestrogens (e.g., black cohosh, red clover, or soy) radiotherapy * see disease characteristics surgery * see disease characteristics other * no concurrent hypericum perforatum (st. john's wort)

Keywords: osteoporosis stage i breast cancer stage ii breast cancer menopausal symptoms hot flashes