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NRG-BR002

Trial

Clinical Trial Title

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

Trial Status

Closed to Enrollment

Start Date

June 5, 2018

Trial Type

Cancer - Adult Oncology

Specific Condition

Breast Cancer

Description

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.

Eligibility Criteria

  • Pathologically confirmed metastatic breast cancer
  • Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
  • 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
  •     central lung
  •     abdominal–pelvic(lymph node/adrenal gland)    
  • Maximum diameter of individual metastasis in any dimension ≤ 5 cm

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:50 PM