Status:
ACTIVE_NOT_RECRUITING
ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES
Lead Sponsor:
Zetagen Therapeutics, Inc
Conditions:
Metastatic Breast Cancer in the Spine
Eligibility:
FEMALE
22-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 ly...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05280067
Start Date
September 1 2022
End Date
December 1 2025
Last Update
July 20 2025
Active Locations (2)
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1
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V5Z 1M9
2
McGill University Health Center
Montreal, Quebec, Canada, H3G1A4