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

You may be eligible if

• 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