UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Colección de datos
Enfermedades Óseas Metabólicas+10
+ Enfermedades de los Huesos
+ Enfermedades de la Mama
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 1 de marzo de 2002
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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)
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Institute of Cancer Research - UK
Sutton, United KingdomAbrir Institute of Cancer Research - UK en Google Maps