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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

Primary Objectives 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) Secondary Objectives To evaluate treated metastasis control according to tumor receptor status (ER, PR, HER-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to greater than or equal to 2 to less than or equal to 4 following completion of a Phase I trial) 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 greater than or equal to 2 to less than or equal to 4 following completion of the Phase I NRG-BR001 trial). To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone. 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. Translational Research Objectives Primary Objective To determine whether less than 5 CTCs (per 7.5ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer Secondary Objectives To determine whether less than 5 CTCs (per 7.5ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer To determine whether eliminating CTCs (0/7.5ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS To store material for retrospective analysis of ctDNA. To store material for retrospective analysis of circulating microRNA.

Primary Objectives 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) Secondary Objectives To evaluate treated metastasis control according to tumor receptor status (ER, PR, HER-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to greater than or equal to 2 to less than or equal to 4 following completion of a Phase I trial) 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 greater than or equal to 2 to less than or equal to 4 following completion of the Phase I NRG-BR001 trial). To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone. 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. Translational Research Objectives Primary Objective To determine whether less than 5 CTCs (per 7.5ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer Secondary Objectives To determine whether less than 5 CTCs (per 7.5ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer To determine whether eliminating CTCs (0/7.5ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS To store material for retrospective analysis of ctDNA. To store material for retrospective analysis of circulating microRNA.