hormone replacement therapy for hot flashes and/or vaginal symptoms in postmenopausal women receiving tamoxifen for breast cancer

Conditions: Breast Cancer; Hot Flashes; Menopausal Symptoms

Summary: rationale: hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer. purpose: randomized phase iii trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.

objectives: * determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen. * determine the effect of this regimen on blood coagulation and lipid profiles in these patients. * determine the quality of life of patients treated with this regimen. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or more), and average daily number of hot flashes (less than 10 or none vs 10 or more). patients are randomized to one of two treatment arms. * arm i: patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months. if, after 1 month, symptoms do not resolve, patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months. patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months. * arm ii: patients receive oral placebo once daily for 6 months. quality of life is assessed at baseline and months 1, 2, 3, and 6. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 120 patients (60 per treatment arm) will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast * no contralateral breast cancer * no recurrent or metastatic disease * completion of active non-hormonal therapy for breast cancer * receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study * hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) and/or * vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency * if uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma and no concurrent endometrial cancer confirmed by pelvic exam within the past year * no active endometriosis * no unexplained vaginal bleeding * hormone receptor status: * estrogen and progesterone receptor status known for patients with invasive breast cancer patient characteristics: age: * 18 and over sex: * female menopausal status: * postmenopausal * no menstrual period for more than 12 months or prior bilateral oophorectomy * must be over 55 years of age or have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified cardiovascular: * no prior superficial or deep venous or arterial thrombosis * no serious venous stasis disease pulmonary: * no pulmonary embolus other: * must be able to read and speak english * no lower extremity trauma, swelling, or tenderness within the past 4 weeks * no active gallbladder disease * no migraine headaches * no other prior malignancy unless curatively treated with no evidence of recurrence * no concurrent seizure disorder requiring anti-seizure medication prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * see disease characteristics * no other concurrent estrogen or hormone replacement therapy * no concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes * no concurrent topical vaginal estrogen cream (e.g., estring or vagifem) for patients with vaginal symptoms only radiotherapy: * not specified surgery: * at least 4 weeks since prior surgery other: * at least 12 months since prior treatment for congestive heart failure * concurrent selective serotonin reuptake inhibitors (ssri) or antidepressants with ssri activity allowed if begun at least 3 months prior to study and continue during study

Keywords: stage i breast cancer stage ii breast cancer breast cancer in situ ductal breast carcinoma hot flashes menopausal symptoms