Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer — PREDIXIIHER2  

HER2-positive Breast Cancer Clinical Trial

Official title: Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The primary aim is to investigate whether the rate of pCR, after optimal neoadjuvant anti-HER2 based systemic therapy, can be increased by addition of atezolizumab.

Secondary aims are to assess safety and tolerability of this treatment combination, and to identify therapy predictive factors for the anti-HER2 monoclonal antibodies trastuzumab and pertuzumab plus-minus atezolizumab with a backbone of chemotherapy, using modern molecular biological investigational procedures with analyses by repeated biopsies from an intra-patient longitudinal study design. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer
• HER2-positive Breast Cancer

• NCT number: NCT03894007
• Study type: Interventional
• Source: Karolinska University Hospital
• Status: Terminated
• Phase: Phase 2
• Start date: May 23, 2019
• Completion date: June 30, 2021