UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Data Collection
Bone Diseases+8
+ Bone Diseases, Metabolic
+ Breast Diseases
Supportive Care Study
Summary
Study start date: March 1, 2002
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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)
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location