NRG-BR002
Terminated
Protocol Information
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
Principal Investigator
Steven Chmura
Status
Terminated
Open to Accrual
December 23, 2014
Open to Accrual
December 24, 2014
Temporarily Closed to Accrual
September 13, 2019
Closed to Accrual
May 27, 2022
Complete
September 4, 2025
Terminated
September 4, 2025
Disease Site
Breast [BR] Breast
Phase
II/III
Developmental Therapeutics
No
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≤ 4 metastases in permissible metastatic sites seen on standard imaging within 60 days prior to registration ( See Protocol eligibility section 3.2.3 ); and at least 1 pathologically confirmed visualized on CT or PET/CT.
Target Accrual
548
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.