NRG BR002; 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
Categories (click each to see list of all clinical trials associated with that category): Breast
Current Status: Open to accrual
Phase: II/III
Principal Investigator: Wahl, Andrew
Contact Information:
Amy Filler-Katz, RN, BSN, CCRP
402-552-2790
afillerkatz@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02364557#eligibility
Summary
PRIMARY OBJECTIVES:
I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] 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 II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III)
SECONDARY OBJECTIVES:
I. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to >= 2 to =< 4 following completion of a Phase I trial).
II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and solitary metastasis vs. 2 metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial).
III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy alone.
IV. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.