ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES

FEASIBILITY STUDY OF ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN THE SPINAL VERTEBRAL BODY: A PHASE 2A, MULTICENTER, OPEN-LABELED, SINGLE-ARM STUDY

ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other 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. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.

This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ 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.

Inclusion Criteria:

• Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
• Life expectancy of 12 months or more.
• Female patient with histologically confirmed diagnosis of primary breast cancer.
• Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
• At least one lytic metastatic lesion located in the vertebral body of the spine.
• Normal spinal alignment.
• SINS ≥3 and ≤9.
• Signed and dated Informed Consent Form (ICF).
• Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires.

Exclusion Criteria:

• Vertebral body collapse.
• Spinal cord compression.
• Known allergy to Investigational Device materials.
• Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
• Current tobacco smoker or stopped smoking in past 6 months.
• Uncontrolled diabetes mellitus, HbAIC cutoff.
• An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
• Currently participating in any investigational trial not related to this trial.
• Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial.
• Pregnant or planning to become pregnant during the trial.