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

NCT05280067 | Completed Phase 2 DMC

• 1 other identifier: ZG-2021-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 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

Metastatic Breast Cancer in the Spine

Keywords

Metastatic Breast Cancer; Bone Metastases; Spine Metastases; Vancouver; Metastatic Breast Cancer to Bone; X-radiation therapy

Outcome Measures

Primary Outcomes (21)

• Number of Skeletal Related Events (SREs)

  SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.

  Day 0 up to Day 180

• Number of subjects with at least one adverse event (AE)

  An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition.

  Day 0 up to Day 180

• Number of subjects with at least one procedure-related AE

  A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure.

  Day 0 up to Day 180

• Number of subjects with at least one device-related AE

  A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device.

  Day 0 up to Day 180

• Change in SINS assessment at 21 days compared to baseline

  The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.

  Day 0 to Day 21 postoperatively

• Change in SINS assessment at 42 days compared to baseline

  The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.

  Day 0 to Day 42 postoperatively

• Change in SINS assessment at 84 days compared to baseline

  The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.

  Day 0 to Day 84 postoperatively

• Change in SINS assessment at 180 days compared to baseline

  The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.

  Day 0 to Day 180 postoperatively

• Change in Short Form 12v2 (SF-12v2) score compared to baseline

  The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 is given at baseline and at 180 days postoperatively.

  Day 0 to Day 180 postoperatively

• Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline

  The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.

  Day 0 to Day 21 postoperatively

• Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline

  The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.

  Day 0 to Day 42 postoperatively

• Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline

  The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.

  Day 0 to Day 84 postoperatively

• Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline

  The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.

  Day 0 to Day 180 postoperatively

• Change in vertebral body defect size measured by CT at 42 days compared to baseline

  Vertebral body defect size measured by CT

  Day 0 to Day 42 postoperatively

• Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline

  Vertebral body defect size and planar radiographs

  Day 0 to Day 42 postoperatively

• Change in vertebral body defect size measured by CT at 180 days compared to baseline

  Vertebral body defect size measured by CT

  Day 0 to Day 180 postoperatively

• Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline

  Vertebral body defect size measured by planar radiographs

  Day 0 to Day 180 postoperatively

• Duration of use of postoperative prescription opioid

  The average per group duration of intake of opioids in the post-operative setting.

  Day 180 postoperatively

• Daily dose of postoperative prescription opioid use

  The average per group dosage of opioids in the post-operative setting.

  Day 180 postoperatively

• Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure

  Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia

  30 minutes following the placement of the surgical bandage

• Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure

  Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia

  60 minutes following the placement of the surgical bandage

Study Arms (1)

Investigational Device ZetaMet™

EXPERIMENTAL

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.

Combination Product: ZetaMet™ (ZetaFuse™ Bone Graft)

Interventions

ZetaMet™ (ZetaFuse™ Bone Graft) COMBINATION_PRODUCT

ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.

Investigational Device ZetaMet™

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zetagen Therapeutics, Inc: lead

Study Sites (2)

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V5Z 1M9, Canada

Location

McGill University Health Center

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 15, 2022
• Study Start: September 1, 2022
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)