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El ensayo clínico NCT06806930 para Etapa I del cáncer de mama, Cáncer de mama en estadio II, Cáncer de mama en estadio III, Carcinoma de mama está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT) Fase II 90

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Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06806930 está diseñado para estudiar el tratamiento de Etapa I del cáncer de mama, Cáncer de mama en estadio II, Cáncer de mama en estadio III, Carcinoma de mama. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 1 de octubre de 2024, con el objetivo de reclutar a 90 participantes. Dirigido por la Universidad George Washington, se espera que finalice el 1 de octubre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de marzo de 2026.
Resumen

The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:

  1. How breast cancer responds to endocrine therapy given prior to surgery?
  2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or ...
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Título oficial

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Condiciones médicas
Etapa I del cáncer de mamaCáncer de mama en estadio IICáncer de mama en estadio IIICarcinoma de mama
Otros ID del estudio
  • Neo-PREDICT
Número del NCT
NCT06806930
Inicio del estudio (real)
2024-10-01
Última actualización
2026-03-03
Fecha de finalización (estimada)
2028-10
Inscripción (prevista)
90
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
breast
cancer
HER2
carcinoma
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activoCohort A: Short Duration NET
Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Neoadjuvant endocrine therapy
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Comparador activoCohort B: Intermediate Duration NET
Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Neoadjuvant endocrine therapy
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Comparador activoCohort C: Extended Duration NET
Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Neoadjuvant endocrine therapy
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Response to neoadjuvant endocrine therapy (NET)
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \>1mm; Failure is defined as margins ≤1mm.
From enrollment to the end of treatment at <=52 weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.
From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.
From enrollment to the end of treatment at <=52 weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
21 Years
Criterios de sexo
Todos
  • Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  • Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  • Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
  • Clinical stage 1 to 3 breast cancer
  • Candidate for surgical resection
  • Estrogen receptor > 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
  • HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
  • Ability to take oral medication
  • Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
  • Age ≥ 21 years

  • Inability to comply taking NET
  • Inability to comply to study procedures
George Washington University logoUniversidad George Washington
Parte responsable del estudio
Pavani Chalasani, Investigador principal, Professor of Medicine; Director, Division of Hematology Oncology, George Washington University
Contactos centrales del estudio
Contacto: Pavani Chalasani, MD, 202-741-2277, [email protected]
1 Centros del estudio en 1 países

District of Columbia

George Washington-Medical Faculty Associates, Washington D.C., District of Columbia, 20037, United States
Richard Lush, PhD, Contacto, 202-994-0329, [email protected]
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