NRG-BR002

Terminated

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Protocol Information

Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants

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.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.