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New bone graft shows promise for repairing Cancer-Damaged spines

NCT ID NCT05280067

Disease control Sponsor: Zetagen Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new bone graft material, ZetaMet, in 10 women with breast cancer that spread to their spine, causing bone defects. The graft was implanted into the damaged vertebra to see if it could safely stabilize the spine and reduce pain. The main goals were to track complications, pain levels, and spine stability over six months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 pregnant during the trial.

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm metastatic carcinoma in the bone

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer in the spine

Contacts and locations

Locations

  • McGill University Health Center

    Montreal, Quebec, H3G1A4, Canada

  • Vancouver Coastal Health Research Institute

    Vancouver, British Columbia, V5Z 1M9, Canada

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