- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00131924
High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy.
PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (Menest^®).
Secondary
- Determine time to disease progression in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive oral high-dose esterified estrogens (Menest^®) 3 times daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 2 months.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 2 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
- Metastatic disease
Documented disease progression
Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
- Disease progression during adjuvant tamoxifen is considered 1 prior therapy
- The 2 most recent treatments must have been endocrine agents
- At least 1 objective measurable disease parameter
Brain metastases allowed provided both of the following criteria are met:
- Brain metastases were previously treated AND are currently stable
- Brain metastases are not the only site of metastatic disease
Hormone receptor status
- Estrogen and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
Postmenopausal, as defined by any of the following:
- At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months
- At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range
- Under 50 years of age and FSH level within postmenopausal range
- Prior bilateral oophorectomy
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Adequate hematologic function
Hepatic
- Adequate hepatic function
- Bilirubin ≤ 1.5 times upper limit of normal
- No history of hepatic adenoma
Renal
- Adequate renal function
- No history of hypercalcemia or severe hypocalcemia
Cardiovascular
- No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
- No active thrombophlebitis or thromboembolic disorders
- No history of uncontrolled hypertension
Other
- Not pregnant
- No undiagnosed abnormal vaginal bleeding
- No other serious medical illness
- No psychiatric illness that would preclude giving informed consent
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior chemotherapy for metastatic disease allowed
- Prior adjuvant chemotherapy allowed
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Prior radiotherapy allowed provided the only site of measurable disease was not irradiated
Surgery
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Tasa de respuesta clínica
|
Medidas de resultado secundarias
Medida de resultado |
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Toxicidad
|
Tiempo hasta la progresión de la enfermedad
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: William J. Gradishar, MD, Robert H. Lurie Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCI 03B5
- NU-03B5
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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