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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen

Conditions
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Breast Cancer, Hot Flashes, Menopausal Symptoms

Intervention / Treatment
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* Drug: conjugated estrogens
* Drug: medroxyprogesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: conjugated estrogens|nan|
|Drug: medroxyprogesterone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, breast cancer in situ, ductal breast carcinoma, hot flashes, menopausal symptoms