This is an open-label single-arm study. Subjects (N=10) will be recruited from a single Investigational Site in Canada. Key inclusion criteria are oligometastatic primary breast cancer (≤5 metastatic lesions located at ≤3 tissue sites) with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. The ZetaFuse™ Bone Graft will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.
The ZetaFuse™ Bone Graft is indicated for patients with destructive, lytic lesions due to oligometastatic cancer (≤5 metastatic lesions located at ≤3 tissue sites), with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.