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

Inclusion 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