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 range

22 Years – 75 Years

Sex

FEMALE

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

22 Years – 75 Years

Sex

FEMALE

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