Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer. PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Compare disease-free survival and overall survival of postmenopausal women with prior stage I or II breast cancer treated with hormone replacement therapy (HRT) vs nonhormonal alternatives to HRT. Compare relief of menopausal symptoms and quality of life of patients treated with these regimens. Compare cardiovascular and osteoporotic events in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs > 2 to < 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without progesterone for at least 2 years. Arm II: Patients are offered advice on nonhormonal HRT alternatives. Menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter. Patients are followed every 6 months for 3 years and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study.

Official Title
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UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer

Conditions
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Breast Cancer, Hot Flashes, Menopausal Symptoms, Osteoporosis

Intervention / Treatment
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* Biological: therapeutic progesterone
* Drug: conjugated estrogens


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Prior diagnosis of stage I or II breast cancer No clinical evidence of recurrence Meets criteria for 1 of the following: Amenorrheic for at least the past 6 months Radiotherapy- or chemically-induced ovarian suppression allowed Prior surgical bilateral oophorectomy Experiencing vasomotor symptoms (i.e., hot flashes or night sweats) with or without vaginal dryness No undiagnosed postmenopausal bleeding No ductal carcinoma in situ or lobular carcinoma in situ alone Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Postmenopausal Sex Female Menopausal status Postmenopausal Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic No severe, active liver disease with abnormal liver function tests No acute, intermittent porphyria Fibrinolysis and coagulation normal Renal Not specified Cardiovascular No prior deep vein thrombosis Thrombophlebitis or superficial phlebitis alone allowed No prior retinal vein thrombosis Pulmonary No prior pulmonary embolism Other Not pregnant No prior alcohol, drug, or chemical abuse No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy Endocrine therapy More than 3 months since prior oral or transdermal hormone replacement therapy (HRT) More than 5 years since prior HRT implant No other concurrent HRT No concurrent gonadotropin-releasing hormone agonists (e.g., goserelin) if less than 2 years of planned treatment remains No other concurrent low-dose progestins No concurrent tibolone No concurrent phytoestrogens (e.g., black cohosh, red clover, or soy) Radiotherapy See Disease Characteristics Surgery See Disease Characteristics Other No concurrent Hypericum perforatum (St. John's wort)
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic progesterone|nan|
|Drug: conjugated estrogens|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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hot flashes, osteoporosis, stage I breast cancer, stage II breast cancer, menopausal symptoms