23-01A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
Axillary lymph node dissection
+ No axillary lymph node dissection
Enfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 2001
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection. * Compare overall survival of patients treated with these regimens. * Assess sites of recurrence, particularly reappearance of disease in the undissected axilla. * Assess long-term surgical complications in patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 931 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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.A partir de 18 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: * Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma * Largest tumor lesion ≤ 5 cm * Palpable or nonpalpable breast lesion * Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions * Prior (preoperative) or planned (intraoperative) sentinel node biopsy required * At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension * No clinical evidence of distant metastases * No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following: * Skeletal pain of unknown cause * Elevated alkaline phosphatase * Bone scan showing hot spots * No palpable axillary lymph node(s) * No Paget's disease without invasive cancer * Hormone receptor status: * Estrogen receptor and progesterone receptor known PATIENT CHARACTERISTICS: Age * Any age Sex * Female Menopausal status * Any status Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * See Disease Characteristics Renal * Not specified Other * Not pregnant or nursing * No other prior or concurrent malignancy except the following: * Adequately treated basal cell or squamous cell skin cancer * Adequately treated carcinoma in situ of the cervix * Adequately treated in situ melanoma * Contralateral or ipsilateral carcinoma in situ of the breast * No psychiatric, addictive, or other disorder that may compromise ability to give informed consent * Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No prior systemic therapy for breast cancer * More than 1 year since prior chemopreventive agent
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 31 ubicaciones
Lismore Base Hospital
Lismore, AustraliaSt Vincents Hospital
Lismore, AustraliaMater Hospital - North Sydney
North Sydney, Australia