Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Eastern Cooperative Oncology Group

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Breast Cancer Hot Flashes Menopausal Symptoms

Interventions

conjugated estrogensDRUG

medroxyprogesteroneDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

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Data from ClinicalTrials.gov

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