MOUNTAINEER-03 (Colorectal Cancer) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to see how tucatinib, trastuzumab, and mFOLFOX6 work to treat cancer of your colon or rectum that is HER2-positive with mFOLFOX6 alone or combined with bevacizumab.
¿Cuál es la Condición que se está estudiando?
Cáncer colorrectal
¿Quién puede participar en el Estudio?
Adults with colorectal cancer who:
- Have HER2+ mutation
- Able to swallow oral medication
- Have not had prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting
For more information about who can join this study, please contact the study team at sabina.wlazlo@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
If you choose to join this study, you will get a random assignment (like the flip of a coin) to Group 1 or Group 2:
- Group 1 will take tucatinib pills, mFOLFOX6 will be given into a vein (intravenous, "IV"), and trastuzumab will be given by IV.
- Group 2 will get mFOLFOX6 by IV and bevacizumab by IV.
Los participantes de ambos grupos:
- Realizar extracciones de sangre
- Proporcionar muestras de orina
- Realice tomografías computarizadas o resonancias magnéticas de manera regular.
- Have other tests done during your clinic visits
Detalles del Estudio
Título Completo
An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer (SGNTUC-029; MOUNTAINEER-03)
Investigador Principal
Especialista en oncología médica
Número de Protocolo
IRB:
PRO00110153
NCT:
NCT05253651
Fase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción