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NRG BR003

Trial Overview

Official Title

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

Study Purpose

To compare the good and bad effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin.

Diagnosis

Breast cancer that has higher risk features (i.e. – positive lymph nodes and/or large size)

Eligibility



Patients must have undergone a lumpectomy or mastectomy.

Patients cannot have had any prior chemotherapy.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Study agents: Doxorubicin, Cyclophosphamide, Paclitaxel, Carboplatin
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM A: Doxorubicin + Cyclophosphamide x 4 cycles, followed by Paclitaxel
  • ARM B: Doxorubicin + Cyclophosphamide x 4 cycles, followed by Paclitaxel + Carboplatin

After completion of study therapy, patients are followed for at least 10 years.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center Methodist Jennie Edmundson Hospital
Gender
Male or Female
Age
19 years and older
Marker Status
Triple Negative (ER, PR, and Her-2 Negative)
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
NRG BR003
Related Specialties