drugset / Trial / NCT03595592

Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer

NCT03595592

Phase 3 Active not recruiting 650 enrolled Fondazione Michelangelo Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelOther

Summary

n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.

Timeline

Start
2018-09-07
Primary completion
2026-12-15
Completion
2027-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Carboplatin Small molecule 2 unknown Intravenous
Background Paclitaxel Small molecule 90 mg/m2 Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous