Radioterapia guiada genómicamente en el tratamiento del cáncer de mama triple negativo
Estudio de fase II de personalización de dosis de radiación guiada genómicamente en el tratamiento del cáncer de mama triple negativo
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kamran Ahmed, MD
- Número de teléfono: 813-745-3320
- Correo electrónico: Kamran.Ahmed@moffitt.org
Copia de seguridad de contactos de estudio
- Nombre: Robin Dowell
- Número de teléfono: 813-745-0393
- Correo electrónico: Robin.Dowell@moffitt.org
Ubicaciones de estudio
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33756
- Reclutamiento
- Morton Plant Hospital - Baycare Health System
-
Contacto:
- Ken Tardif
- Número de teléfono: 727-462-3921
- Correo electrónico: Ken.Tardif@baycare.org
-
Investigador principal:
- Ronica H. Nanda, MD
-
Tampa, Florida, Estados Unidos, 33612
- Reclutamiento
- Moffitt Cancer Center
-
Investigador principal:
- Kamran Ahmed, MD
-
Investigador principal:
- Ronica H Nanda, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
- Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
- Adequate tissue to calculate RSI
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
- To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
- Life expectancy >16 weeks
- KPS ≥ 70
- Age ≥ 18 years
- Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- There is no limit on prior systemic therapies
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
Exclusion Criteria:
- Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Metastatic breast cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Radiosensitivity Index optimized
Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
|
Comparador activo: Radiosensitivity Index not optimized
Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Local Control
Periodo de tiempo: At 3 Years
|
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging |
At 3 Years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS)
Periodo de tiempo: Up to 5 Years
|
OS will be measured from the date of study initiation to the date of death due to any cause. |
Up to 5 Years
|
|
Progression Free Survival (PFS)
Periodo de tiempo: Up to 5 years
|
PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause. |
Up to 5 years
|
|
Distant Control
Periodo de tiempo: Up to 5 Years
|
Distant control will be defined by lack of progression outside the irradiated treatment field |
Up to 5 Years
|
|
Quality of Life following Genomically Guided Dose Personalization
Periodo de tiempo: Up to 5 Years
|
Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits |
Up to 5 Years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kamran Ahmed, MD, Moffitt Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-21757
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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