Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
Colección de datos
Enfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Resumen
Fecha de inicio: 26 de enero de 2005
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27. Secondary * Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens. * Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens. OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27. Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at baseline and at 3, 6, 12, and 24 months. PROJECTED ACCRUAL: A total of 1,253 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.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.Hasta 120 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * pT1-3; pNX, pN0-2 or pN3\*; M0 NOTE: \*Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes * Registered on protocol CAN-NCIC-MA27 within the past week * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein * At least 1 tumor must be receptor-positive in patients with bilateral breast cancer PATIENT CHARACTERISTICS: Age * Postmenopausal Performance status * ECOG 0-2 Sex * Female Menopausal status * Postmenopausal Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Able to read, understand, and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified 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 224 ubicaciones
Meeker County Memorial Hospital
Litchfield, United StatesAbrir Meeker County Memorial Hospital en Google MapsSt. John's Hospital
Maplewood, United StatesVirginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, United StatesCentraCare Clinic - River Campus
Saint Cloud, United States