Surgery or high-dose radiation for Breast Cancer Survival

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

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Ford, Elizabeth

    Trial Phone: 321.841.7413

  • IRB No: NRG-BR002

    Principal Investigator: Patrick Kelly, MD, PhD

    Sub Investigators: Buchholz, Daniel MD; Dvorak, Tomas MD; Rineer, Justin MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: NRG-BR002

    Treatment: Chemotherapy

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: SBRT and surgical resection

    ClinicalTrials.gov ID: NCT02364557

  • Objective

    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

  • Key Eligibility

    18 Years and older with Pathologically confirmed metastatic breast cancer within 270 days prior to registration