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NRG-BR002

NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

NRG-BR001 and NRG-BR002 PowerPoint Presentation

Principal Investigator/Co-Principal Investigator

Steven Chmura, MD, PhD

Julia R. White, MD

Primary Objective

Phase II-R:  To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial.

Phase III:  To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS) 

Patient Population

Patients with locally controlled metastatic breast cancer with the following number of allowable metastases:

  •  ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites: peripheral lung; osseous (bone); spine

  •  ≤ 2 metastases seen on standard imaging within 60 days prior to registration when any one metastasis is located in one of the following sites: liver; central lung; mediastinal/cervical lymph node; abdominal-pelvic metastases (lymph node/adrenal gland)

and at least 1 pathologically confirmed visualized on CT or PET/CT.

Target Accrual

402 patients (including the 146 already accrued in the Phase II-R portion)

Status

Activated December 24, 2014

Protocol Documents

The protocol and related documents are available at the National Cancer Institute Cancer Trials Support Unit (CTSU) website.

RT Credentialing and Treatment Planning Materials

Click here to visit the IROC website for extensive information about benchmark case planning, credentialing, and treatment planning guidelines.


Copyright 2017 by NRG Oncology