- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02489409
Recombinant Human Endostatin (EndostarTM) Injection in Treatment of Recurrent Metastatic Breast Cancer
12 de julio de 2017 actualizado por: Shun-E Yang, Xinjiang Medical University
EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Large amounts of studies have proved that the development of tumor vessels mainly depend on the activation, proliferation, adhesion and maturity of vascular endothelial cells, which may also become the targets of vascular inhibitors.
At present, Avastin, an anti-angiogenesis drug, has been marketed in Euopean and American countries, and another 30 kinds of vascular inhibitors are still in trails.
Endostatin has been widely applied for the clinical treatment of partial primary and metastatic solid tumors.
Endostatin combined with chemotherapy has achieved favorable progression in the treatment of non-small cell lung cancer (NSCLC).
However, the research about the efficacy of Endostatin on breast cancer has just started.
Breast cancer is a highly-differentiated solid tumor, indicating that it is also an indicator for Endostatin therapy.
Additionally, after chemo- and radiotherapy, the primary nidi of patients with advanced breast cancer may also lead to rapid development of tumors in other locations.
So Endostatin combined with chemotherapy can also improve the prognosis of patients with recurrent metastatic breast cancer, but there is rare any report at home and abroad.
To further explore the above research, this study designed a randomized, opened and controlled clinical study to observe the clinical efficacy of EndostarTM Injection combined with GP/NP/GX/NX in the treatment of recurrent metastatic breast cancer.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Xinjiang
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Urumchi, Xinjiang, Porcelana, 830000
- Reclutamiento
- Third Affiliated Hospital of Xinjiang Medical University
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Contacto:
- Shun-E Yang, Professor
- Número de teléfono: 15805197983
- Correo electrónico: 319889719@qq.com
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Contacto:
- Xun Li, Assistant
- Número de teléfono: 7819371 0991-7819372
- Correo electrónico: yangshune@medmail.com.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Age: 18~70 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0~1 score;
- All patients were diagnosed as recurrent metastatic breast cancer retreatment by histopathology and computed tomography (CT) examination;
- The measurable nidus≥1: Patients whose nidus diameter ≥ 20 mm by normal CT or magnetic resonance image (MRI) scanning, and ≥ 10 mm by spiral CT scanning;
- Patients whose blood routine, hepatorenal function, electrolyte and cardiac function were basically normal without dysfunction of primary organs. White blood cell count (WBC) ≥4.0×109/L, neutrophile granulocyte count ≥1.5×109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥95 g/L, serum bilirubin (BIL) ≤1.5-fold upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2-fold upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- The expected survival time >3 months;
- Patients who could understand this study status and had signed the informed consent forms.
Exclusion Criteria:
- Patients who had history of allergic responses to biological agents;
- Patients who were receiving other anti-tumor therapies;
- Patients without measureable nidus;
- Others, including one of the following conditions: patients with uncontrolled central nervous system (CNS) metastatic nidi, with dysfunction of important organs and severe cardiac diseases (congestive heart failure, uncontrollable arrhythmia, and angina pectoris, valvular heart disease, myocardial infarction and refractory hypertension that required long-term drug administration), with chronic infectious wound and with history of uncontrollable psychosis, and women in pregnant or lactation period.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experimental group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14; EndostarTM Injection: 210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h).
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210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
Otros nombres:
1.0 m/m2, iv 0.5h, d1, 8
Otros nombres:
40 mg/d, iv, d1, 8
Otros nombres:
30 mg/m2, iv 3h, d1-3
Otros nombres:
2 000 mg/m2, po, d1-14
Otros nombres:
|
Comparador activo: Control group
Gemcitabine (Gem): 1.0 m/m2, iv 0.5h, d1, 8; Navelbine (NVB): 40 mg/d, iv, d1, 8; Platinum (DDP): 30 mg/m2, iv 3h, d1-3; Xeloda Tablets: 2 000 mg/m2, po, d1-14.
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1.0 m/m2, iv 0.5h, d1, 8
Otros nombres:
40 mg/d, iv, d1, 8
Otros nombres:
30 mg/m2, iv 3h, d1-3
Otros nombres:
2 000 mg/m2, po, d1-14
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
response rate
Periodo de tiempo: 2 years
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response rate that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment.
ORR=(CR+ CRu+ PR)cases/total cases×100%.
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
clinical benefit rate
Periodo de tiempo: 2 years
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clinical benefit rate that defined as the total ratio of study subjects with complete response,partial response and stable disease more than 24 months after treatment.
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2 years
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progression-free survival
Periodo de tiempo: 2 years
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Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died from the start of randomization.
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2 years
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median survival time
Periodo de tiempo: 2 years
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median survival time defined as the corresponding survival time when the cumulative survival rate is 50%.
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2 years
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overall survival
Periodo de tiempo: 2 years
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overall survival rate (OS) that defined as the ratio of study subjects who survived after randomization
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2 years
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adverse responses
Periodo de tiempo: 2 years
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adverse responses that defined as the evaluated by rates of all adverse reactions caused by Recombinant Human Endostatin and the changes of all indexes before and after treatment
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2 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shun-E Yang, Professor, Third Affiliated Hospital of Xinjiang Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2015
Finalización primaria (Anticipado)
1 de mayo de 2018
Finalización del estudio (Anticipado)
1 de julio de 2018
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2015
Publicado por primera vez (Estimar)
3 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Gemcitabina
- Vinorelbina
- Endostatinas
Otros números de identificación del estudio
- XinjiangMU001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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