NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Principal Investigator

Vicente Valero, MD

Primary Objective

To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.

Patient Population

Patients with operable node-positive or high-risk node-negative triple-negative breast cancer who have undergone either a mastectomy or lumpectomy.

Target Accrual

990 patients


Pre-activation:  June 11, 2015

Activation:  June 26, 2015

Canada Activation:  August 24, 2015

Protocol and Other Documents

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

A slide set overview of this trial is available here.

Site Initiation Visit Video

To access the site initiation video click here (You will be prompted to enter your CTEP IAM credentials to access the materials.)

Copyright 2017 by NRG Oncology