CompletedPhase 2

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

Canada10 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range22 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pregn…

What they're measuring

Number of Skeletal Related Events (SREs)

Timeframe: Day 0 up to Day 180

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

Timeframe: Day 0 up to Day 180

Number of subjects with at least one procedure-related AE

Timeframe: Day 0 up to Day 180

Number of subjects with at least one device-related AE

Timeframe: Day 0 up to Day 180

Change in SINS assessment at 21 days compared to baseline

Timeframe: Day 0 to Day 21 postoperatively

Change in SINS assessment at 42 days compared to baseline

Timeframe: Day 0 to Day 42 postoperatively

Change in SINS assessment at 84 days compared to baseline

Timeframe: Day 0 to Day 84 postoperatively

Change in SINS assessment at 180 days compared to baseline

Timeframe: Day 0 to Day 180 postoperatively

Trial details

NCT IDNCT05280067

SponsorZetagen Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Metastatic Breast Cancer in the Spine trials

Plain-language summary

Who can participate

Age range22 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Skeletal Related Events (SREs)

Timeframe: Day 0 up to Day 180

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

Timeframe: Day 0 up to Day 180

Number of subjects with at least one procedure-related AE

Timeframe: Day 0 up to Day 180

Number of subjects with at least one device-related AE

Timeframe: Day 0 up to Day 180

Change in SINS assessment at 21 days compared to baseline

Timeframe: Day 0 to Day 21 postoperatively

Change in SINS assessment at 42 days compared to baseline

Timeframe: Day 0 to Day 42 postoperatively

Change in SINS assessment at 84 days compared to baseline

Timeframe: Day 0 to Day 84 postoperatively

Change in SINS assessment at 180 days compared to baseline

Timeframe: Day 0 to Day 180 postoperatively