A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
pegfilgrastim
+ docetaxel
+ conventional surgery
Enfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 11 de agosto de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer. Secondary * Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen. * Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen. * Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen. OUTLINE: This is a pilot study. * Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician. * Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician. * Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician. * Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 40 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 19 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: * Histologically confirmed infiltrating carcinoma of the breast * Unresected clinical stage T1c, T2, T3, or T4 lesion, any N * Newly diagnosed disease * Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry * Mammogram of the contralateral breast within 6 months before study entry * Clinically measurable disease * Hormone receptor status: * Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic * Bilirubin no greater than 1.5 times normal Renal * Creatinine no greater than 1.5 times normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for current breast cancer Endocrine therapy * At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention * No prior endocrine therapy for current breast cancer Radiotherapy * No prior radiotherapy for current breast cancer Surgery * Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
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 una ubicación