NCT05280067CompletedPhase 2
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 · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 28 Jan 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 10 Oct 2025
- Lead sponsor
- Zetagen Therapeutics, Inc
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05280067
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 10
- From 1 Sept 2022 to the primary completion date, 10 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Uncontrolled diabetes mellitus, HbAIC cutoff.
- An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
- 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.
Other
- Vertebral body collapse.
- Spinal cord compression.
- Current tobacco smoker or stopped smoking in past 6 months.
- Currently participating in any investigational trial not related to this trial.
- Pregnant or planning to become pregnant during the trial.
Who the study is looking for
- 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.
Age in the registry: 22 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Vancouver Coastal Health Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.