Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer in the Spine | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZetaMet™ (ZetaFuse™ Bone Graft) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Device ZetaMet™
- description
- 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.
- interventionNames
- Combination Product: ZetaMet™ (ZetaFuse™ Bone Graft)
Primary outcomes (21)
- measure
- Number of Skeletal Related Events (SREs)
- timeFrame
- Day 0 up to Day 180
- description
- SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.
- measure
- Number of subjects with at least one adverse event (AE)
- timeFrame
- Day 0 up to Day 180
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available