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Amonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Enfermedades de la Mama
+2

+ Neoplasias de la Mama
+ Neoplasias
A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: agosto de 2003
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 1 de agosto de 2003Fecha en la que se inscribió al primer participante.

OBJECTIVES: Primary * Determine the time to progression in women with metastatic breast cancer who have progressed after prior chemotherapy and are now treated with amonafide. * Determine the overall response rate (complete and partial response) in patients treated with this drug. * Determine the safety of a phenotypically driven dosing regimen of this drug in these patients. Secondary * Determine the time to tumor response, duration of response, and time to treatment failure in patients treated with this drug. * Determine the overall survival of patients treated with this drug. * Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive amonafide IV over 1 hour on days 1-5. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses (beyond 5 courses) at the investigator's discretion. Patients are followed at 30 days and then every 3 months. PROJECTED ACCRUAL: A total of 175 patients will be accrued for this study within 1 year.

Título OficialAmonafide: Individual Phenotype-Adjusted Chemotherapy for Women With Metastatic Breast Cancer Who Have Progressed Despite Prior Chemotherapy 
NCT00074100
Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Todos los involucrados en el estudio saben qué tratamiento se está administrando. Esto se utiliza cuando no es posible o necesario ocultar los detalles del tratamiento a los participantes o investigadores.

Otras formas de enmascarar la información
Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Doble ciego
: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
MujerSexo biológico de los participantes elegibles para inscribirse.
A partir de 18 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Enfermedades de la Mama
Neoplasias de la Mama
Neoplasias
Neoplasias por Sitio
Enfermedades de la Piel
Criterios

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic (stage IV) disease * Relapsed after 1 of the following prior therapy regimens\*: * Adjuvant therapy containing an anthracycline and a taxane * Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: \*No relapse within 12 months of initiation of prior therapy * Measurable disease by CT scan or MRI * No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease * Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy * HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®) * MUGA or echocardiogram normal while on trastuzumab * No known history of or current brain or leptomeningeal metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL * No clinically significant abnormal hematological parameters Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases) * AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * See Disease Characteristics * No myocardial infarction within the past 3 months * No unstable angina pectoris * No New York Heart Association class III or IV heart disease * No uncontrolled arrhythmia * No cardiac insufficiency * No uncontrolled hypertension * LVEF at least 50% OR at least lower limit of normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation * No preexisting neuropathy (motor or sensory) greater than grade 2 * No clinically significant abnormal biochemical parameters * No clinically significant active infection * No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No other serious illness or medical condition * No psychological illness or condition that would preclude study participation * No other known condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 3 months since prior trastuzumab * More than 2 weeks since prior growth factor therapy (i.e., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * No concurrent systemic anticancer immune modulators Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics * More than 4 weeks since prior hormonal therapy * No concurrent anticancer hormonal therapy * No concurrent chronic systemic steroids * Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment * Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment Radiotherapy * More than 30 days since prior radiotherapy * No concurrent radiotherapy directed at target lesions Surgery * At least 4 weeks since prior major surgery and recovered Other * More than 30 days since prior investigational new drug * More than 2 weeks since prior blood transfusion * No other concurrent systemic anticancer agents, including immunosuppressive agents * No other concurrent investigational agents * Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment

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
Suspendido
Memorial Sloan-Kettering Cancer CenterNew York, United StatesVer ubicación
Completado1 Centros de Estudio