A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de febrero de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction. * Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug. * Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug. Secondary * Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients. * Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug. OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction). Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 53 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
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.De 20 a 45 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction * Undergoing mammography at least annually * No bilateral breast cancer or stage IV breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 20 to 45 Sex * Female Menopausal status * Premenopausal * No change in menstrual patterns within the past 6 months Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * No planned pregnancy within the next 5 years * No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for breast cancer Endocrine therapy * See Disease Characteristics * No prior tamoxifen for more than 1 month in duration Radiotherapy * Not specified Surgery * Not specified
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesVer ubicación