Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
This trial is active, not recruiting.
|Conditions||breast cancer, hot flashes, menopausal symptoms, osteoporosis|
|Treatments||therapeutic progesterone, conjugated estrogens|
|Sponsor||Institute of Cancer Research, United Kingdom|
|Start date||March 2002|
|Trial identifier||NCT00079248, CDR0000355122, CRUK-HRT, EU-20112, ISRCTN29941643|
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.
|Primary purpose||supportive care|
Female participants of any age.
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)
|Official title||UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer|
|Description||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.|
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