- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01928186
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
Descripción general del estudio
Estado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.
SECONDARY OBJECTIVES:
I. Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.
II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.
OUTLINE:
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
- Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
- Have tissue block available from core biopsy for correlative biomarkers and genomic assay
Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as
- A prior documented bilateral oophorectomy, or
- A history of at least 12 months without spontaneous menstrual bleeding, or
- Age 60 or older with a prior hysterectomy without oophorectomy, or
- Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab
- Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
- Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed
- Be a candidate for [18F]FLT PET imaging
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
- Be willing and able to comply with scheduled visits and other trial procedures
Exclusion Criteria:
- Current use of aromatase inhibitor as prevention or treatment for breast cancer
- Life expectancy of less than two months
- HER2/neu positive by IHC and/or another FDA approved HER2 testing method
- Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
- Weight exceeding capacity of imaging table
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
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Estudios correlativos
Someterse a FLT PET
Otros nombres:
Someterse a FLT PET
Otros nombres:
Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans.
This is not an experimental therapy.
This is a standard of care therapy that patients will continue after surgery, when the study is completed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent Change in Net Influx Constant (Ki) by FLT PET
Periodo de tiempo: Baseline to up to 6 weeks
|
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed. Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response. |
Baseline to up to 6 weeks
|
Percent Change in SUV by FLT PET
Periodo de tiempo: Baseline to up to 6 weeks
|
Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
|
Baseline to up to 6 weeks
|
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
Periodo de tiempo: 1 to 6 weeks post-therapy start
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Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.
|
1 to 6 weeks post-therapy start
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Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Periodo de tiempo: Baseline to up to 6 weeks
|
Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation. The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient. Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response. |
Baseline to up to 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Periodo de tiempo: Baseline to up to 6 weeks
|
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
|
Baseline to up to 6 weeks
|
Baseline Ki (Flux Constant) Values by FLT PET
Periodo de tiempo: Baseline
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Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
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Baseline
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Baseline FLT Transport (K1) Values by FLT PET
Periodo de tiempo: Baseline
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K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
|
Baseline
|
Baseline Standardized Uptake Values (SUV) by FLT PET
Periodo de tiempo: Baseline
|
FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
|
Baseline
|
Post-therapy Ki (Flux Constant) Values by FLT PET
Periodo de tiempo: 1 to 6 weeks post-therapy start
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Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
|
1 to 6 weeks post-therapy start
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Post-treatment FLT Transport (K1) Values by FLT PET
Periodo de tiempo: 1 to 6 weeks post-therapy start
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K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
|
1 to 6 weeks post-therapy start
|
Post-treatment Standardized Uptake Values (SUV) by FLT PET
Periodo de tiempo: 1 to 6 weeks post-therapy start
|
FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
|
1 to 6 weeks post-therapy start
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Post-treatment Gene Expression Levels
Periodo de tiempo: 1 to 6 weeks post-therapy start
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Analyzed using BeadStudio software.
Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor.
To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
|
1 to 6 weeks post-therapy start
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Pre-treatment Gene Expression Levels
Periodo de tiempo: Baseline
|
Analyzed using BeadStudio software.
Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor.
To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (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
Otros números de identificación del estudio
- 7536 (Otro identificador: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
- P30CA015704 (Subvención/contrato del NIH de EE. UU.)
- NCI-2013-01380 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- RC1CA146456 (Subvención/contrato del NIH de EE. UU.)
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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