IBIS-II DCISInternational Breast Cancer Intervention Study II (IBIS-II) (DCIS)
tamoxifen citrate
+ Anastrozole
Carcinoma+9
+ Carcinoma in situ
+ Adenocarcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ. * Compare side effect profiles of these drugs in these patients. Secondary * Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients. * Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients. * Compare breast cancer mortality in patients treated with these drugs. * Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients. * Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs. OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tamoxifen and oral placebo once daily. * Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity. Patients are followed annually for 5 years and a further 5 years (minimum) off treatment. Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 2980 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.De 40 a 70 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: * Diagnosis of ductal carcinoma in situ within the past 6 months * Locally excised with tumor-free margins at least 1 mm * Hormone receptor status: * Estrogen or progesterone receptor positive * Equal to or greater than 5% positive cells PATIENT CHARACTERISTICS: Age * 40 to 70 Sex * Female Menopausal status * Postmenopausal, defined as meeting at least 1 of the following criteria: * Over age 60 * Prior bilateral oophorectomy * Age 60 or under with a uterus AND amenorrhea for at least the past 12 months * Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L Performance status * Not specified Life expectancy * At least 10 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No prior deep vein thrombosis * No prior transient ischemic attack * No prior cerebrovascular accident Pulmonary * No prior pulmonary embolism Other * No unexplained postmenopausal bleeding * No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results * No evidence of osteoporosis * Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures * Psychologically and physically suitable for 5 years of study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years. * No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago. * No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago * No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior mastectomy * No planned prophylactic mastectomy Other * At least 3 months since prior unapproved or experimental agents * No concurrent anticoagulants
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
Comparador ActivoObjetivos 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 97 ubicaciones
Austrian Breast & Colorectal Cancer Study Group
Vienna, AustriaBelgium
Leuven, BelgiumChile
Santiago, Chile