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, MD PhD
Status
Terminated
Date Opened To Accrual
December 24 2019
Date Closed to Accrual
May 27 2022
Date of Study Termination
September 04 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
402
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.