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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00638963
Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)
Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of metastatic breast cancer.
- Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
- No clinical sign of brain progression.
- At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy ≥3 months.
- Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
- Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
- Serum creatine <1.5 x ULN.
- Effective contraception if the risk of conception exists.
Exclusion Criteria:
- Concurrent chronic systemic immune therapy not indicated in the study protocol.
- Any investigational agent(s) within 4 weeks prior to entry.
- Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
- Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
- Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
- Known drug abuse/alcohol abuse.
- Legal incapacity or limited legal capacity.
- Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
- Women who are pregnant or breastfeeding.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Temozolomida
|
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
Sin intervención: De observación
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent of Participants With Recurrence of Brain Metastases
Periodo de tiempo: 1 Year
|
The analysis could not be performed due to low enrollment.
|
1 Year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Days With Progression-free Survival (PFS)
Periodo de tiempo: 24, 38, and 52 weeks
|
PFS was defined as the time interval from randomization to objective tumor progression or death from any cause. The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
Number of Days With Disease-free Survival (DFS)
Periodo de tiempo: 24, 38, and 52 weeks
|
DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant). The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
Number of Days With Distant Disease-free Survival (DDFS)
Periodo de tiempo: 24, 38, and 52 weeks
|
DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain). The analysis could not be performed due to low enrollment. |
24, 38, and 52 weeks
|
Number of Days With Brain Recurrence-free Survival (BRFS)
Periodo de tiempo: 24,38, and 52 weeks
|
BRFS was defined as the time interval from randomization to the appearance of brain metastases. The analysis could not be performed due to low enrollment. |
24,38, and 52 weeks
|
Number of Days on Temozolomide Treatment
Periodo de tiempo: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Total Dose of Temozolomide Taken
Periodo de tiempo: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Number of Participants Who Had at Least One Dose Reduction During Treatment
Periodo de tiempo: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Number of Participants Who Had at Least One Treatment Omission During Treatment
Periodo de tiempo: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Number of Participants Who Completed the Third Cycle of Treatment
Periodo de tiempo: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de la piel
- Neoplasias por sitio
- Atributos de la enfermedad
- Enfermedades de los senos
- Neoplasias del Sistema Nervioso Central
- Neoplasias del Sistema Nervioso
- Neoplasias
- Neoplasias de mama
- Reaparición
- Neoplasias Cerebrales
- Neoplasias Segundo Primario
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Temozolomida
Otros números de identificación del estudio
- P05225
- 2007-005491-14 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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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