drugset
drugset / Trial / NCT03894007

Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer

NCT03894007 ↗

Phase 2 Terminated 6 enrolled Renske Altena
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.

Timeline

Start
2019-05-23
Primary completion
2021-06-30
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Epirubicin Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Trastuzumab Monoclonal antibody 600 mg Subcutaneous
Background Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications

HER2 positive breast carcinoma