NRG-BR004

Closed to Accrual

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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

Closed to Accrual

Date Opened To Accrual

March 12 2019

Date Closed to Accrual

May 20 2022

Disease Site

Breast [BR]

Breast

Phase

III

Developmental Therapeutics

Primary Objective

To determine whether theaddition of atezolizumab to a regimen of pertuzumab and trastuzumab combinedwith a taxane (paclitaxel or docetaxel) will improve the progression-freesurvival (PFS), assessed by investigator using RECIST 1.1 criteria, relative tothe addition of a placebo to a regimen of pertuzumab and trastuzumab combinedwith a taxane (paclitaxel or docetaxel) in patients with newly documentedHER2-positive measurable metastatic breast cancer.

Patient Population

Patients with newly documented HER2-positive measurable metastatic breast cancer

Target Accrual

600

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Other

BR004 Request for Supplies from Baylor Serum Bank
BR004 PD-L1 CellCarta Kit

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.

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