NRG-BR004

A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Principal Investigator

Charles Geyer, MD

Status

Disease Site

Breast [BR] Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the progression-free survival (PFS), assessed by investigator using RECIST 1.1 criteria, relative to
the addition of a placebo to a regimen of pertuzumab and trastuzumab combined
with a taxane (paclitaxel or docetaxel) in patients with newly documented
HER2-positive measurable metastatic breast cancer.

Patient Population

Patients with newly documented HER2-positive measurable metastatic breast cancer

Target Accrual

600