Overview

Evaluation of Trastuzumab in Combination With Lapatinib or Pertuzumab in Combination With Trastuzumab-Emtansine to Treat Patients With HER2-positive Metastatic Colorectal Cancer

Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase II multi-center 2-sequential cohorts trial, designed to assess the objective response rate of two anti HER2 combination in advanced disease CRC patients harbouring an amplified HER2 tumor assessed according to HERACLES Diagnostic Criteria by FISH/SISH. Cohort A: monoclonal antibody trastuzumab, used in combination with the small molecule tyrosine kinase inhibitor lapatinib. Cohort B, monoclonal antibody pertuzumab, used in combination with the antibody drug conjugate trastuzumab-emtansine. Please note that cohort A accrual has been closed and endpoint already reached.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione del Piemonte per l'Oncologia
Treatments:
Ado-Trastuzumab Emtansine
Lapatinib
Maytansine
Pertuzumab
Trastuzumab