- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00244959
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.
Secondary
- Determine the change in estrone sulfate levels in patients treated with this drug.
- Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.
- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.
- Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.
- Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.
OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).
Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
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 meeting 1 of the following criteria:
- Ductal carcinoma in situ (DCIS)
Invasive carcinoma
- Stage I-III disease
Must have undergone breast cancer surgery within the past 6 months, including any of the following:
- Mastectomy or lumpectomy with or without radiation
- Sentinel node and/or axillary node dissection
- Re-excision of lumpectomy margins
Intact contralateral breast
- No prior radiation therapy or mastectomy
- Prior biopsies allowed
Hormone receptor status:
- Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
Postmenopausal, defined as 1 of the following:
- At least 60 years of age
- Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry
- Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range
- Underwent prior bilateral oophorectomy
- Underwent prior radiation castration AND amenorrheic for ≥ 6 months
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior or concurrent adjuvant chemotherapy for breast cancer
Endocrine therapy
- No prior aromatase inhibitor
- At least 6 weeks since prior and no concurrent tamoxifen
At least 6 weeks since prior and no concurrent hormone replacement therapy
- Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed
- At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
- No contralateral breast implant
Other
- Concurrent bisphosphonates allowed at the discretion of the treating oncologist
No concurrent consumption of soy supplements
- Concurrent routine dietary consumption of soy-containing foods allowed
- No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Anastrozole
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
|
1 mg orally daily for 12 months
Otros nombres:
treatment received after breast cancer surgery
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in breast density after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in hormone levels after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Comparison between change in breast density with change in hormone levels after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Comparison between change in bone density with change in hormone levels after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment
Periodo de tiempo: 12 months
|
12 months
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Vered Stearns, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publicaciones y enlaces útiles
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
- 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
- Inhibidores de enzimas
- Agentes antineoplásicos
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Antagonistas de hormonas
- Inhibidores de la aromatasa
- Inhibidores de la síntesis de esteroides
- Antagonistas de estrógeno
- Anastrozol
Otros números de identificación del estudio
- J0365 CDR0000446285
- P30CA006973 (Subvención/contrato del NIH de EE. UU.)
- JHOC-J0365 (Otro identificador: SKCCC at Johns Hopkins)
- JHOC-SKCCC-J0365 (Otro identificador: SKCCC at Johns Hopkins)
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. .
Ensayos clínicos sobre Cáncer de mama
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
Ensayos clínicos sobre anastrozole
-
Xuanzhu Biopharmaceutical Co., Ltd.Aún no reclutandoCáncer de mama avanzadoPorcelana
-
The Affiliated Hospital of Qingdao UniversityDesconocidoVoluntarios SaludablesPorcelana
-
The Affiliated Hospital of Qingdao UniversityDesconocidoVoluntarios SaludablesPorcelana
-
Ahon Pharmaceutical Co., Ltd.ReclutamientoCáncer de mama avanzado | Cáncer de mama femeninoPorcelana
-
Massachusetts General HospitalTerminadoSíndrome de Kallmann | Hipogonadismo hipogonadotrópicoEstados Unidos
-
Trans Tasman Radiation Oncology GroupActivo, no reclutandoCáncer de mamaAustralia, Nueva Zelanda
-
Havah Therapeutics Pty LtdTerminadoDensidad mamográficaAustralia
-
University Hospital, Gentofte, CopenhagenSanofiTerminado
-
The Affiliated Hospital of Qingdao UniversityAún no reclutandoNeoplasias | Cáncer de mama | Enfermedades de los senosPorcelana