ZetaFuse™ Bone Graft for Spinal Repair in Breast Cancer

(ZGMBC Trial)

Not currently recruiting at 2 trial locations

Overseen By Joe Loy

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Zetagen Therapeutics, Inc

Must not be taking: Chronic steroids

Disqualifiers: Vertebral collapse, Spinal compression, Diabetes, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bone graft treatment called ZetaFuse™ for individuals with breast cancer that has spread to the bones in the spine. The goal is to determine if ZetaFuse™ can repair bone damage caused by cancer. Participants must have breast cancer that has spread to at least one area in the spine and must not have major spinal deformities or severe medical conditions. This trial aims to improve bone repair and provide a new option for those facing cancer-related spinal issues. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of new therapies.

Will I have to stop taking my current medications?

The trial requires that you do not use medications known to interfere with bone or soft tissue healing, like chronic systemic steroids. If you're on such medications, you may need to stop them to participate.

What prior data suggests that the ZetaFuse™ Bone Graft is safe for spinal repair in breast cancer patients?

Research shows that ZetaMet™ treats bone problems caused by breast cancer spreading to the spine. Doctors can safely place it into the spine using vertebroplasty, a common outpatient procedure. This procedure has been successful in other contexts, indicating it is generally well-tolerated.

Although specific safety data for ZetaMet™ is not yet available, its inclusion in a clinical trial suggests it has shown enough promise to advance beyond early testing. Treatments at this stage have usually demonstrated a basic level of safety in humans. However, like any medical treatment, there may be risks and side effects, which the trial aims to better understand. Prospective participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for spinal repair in breast cancer patients, which often involve surgery or radiation, ZetaMet™ offers a unique solution by being percutaneously implanted directly into the bone defect created by metastatic tumors. This direct delivery method is minimally invasive compared to traditional surgical options, potentially leading to faster recovery times and reduced risk of complications. Researchers are excited about ZetaMet™ because it targets the vertebral body specifically, which could enhance stability and promote bone regeneration more effectively than current treatments.

What evidence suggests that the ZetaFuse™ Bone Graft is effective for spinal repair in breast cancer?

Research shows that ZetaMet™, a treatment participants in this trial may receive, targets bone problems caused by breast cancer that has spread to the spine. Studies have found that this treatment can heal damaged bone areas, slow cancer growth, and reduce pain. By rebuilding bone, ZetaMet™ aims to provide support and enhance patients' quality of life. The treatment is applied directly to the damaged bone area. Early results suggest it may help prevent fractures, offering a strong option for those with spinal instability due to cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 22-75 with breast cancer that has spread to the spine, causing bone defects. They must have a life expectancy of at least 12 months, no more than five metastatic lesions in three sites or less, and be able to attend follow-up visits. Exclusions include spinal cord compression, allergies to device materials, certain medication use, diabetes, active infections like AIDS or hepatitis, recent smokers or those pregnant.

Inclusion Criteria

I have a cancerous lesion in the spine.

I am a woman diagnosed with breast cancer through tissue analysis.

I am between 22 and 75 years old.

Exclusion Criteria

Known allergy to Investigational Device materials

I am not on medications that could affect bone or tissue healing.

I have had a spinal bone collapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

Immediate

1 visit (in-person)

Post-operative Care

Post-operative care will be per standard of care (SOC) at the Investigational Site.

84 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of SINS, pain, and vertebral body defect size.

180 days

What Are the Treatments Tested in This Trial?

Interventions

• ZetaFuse™ Bone Graft

Trial Overview The ZetaFuse™ Bone Graft is being tested on patients with metastatic breast cancer in the spine. It's implanted into bone defects caused by tumors in the vertebral body. The graft aims to repair these defects and improve stability for patients who meet specific criteria regarding their spinal health and number of metastases.

How Is the Trial Designed?

Group I: Investigational Device ZetaMet™ Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Zetagen Therapeutics, Inc

Lead Sponsor

Trials

2

Recruited

20+

Published Research Related to This Trial

The off-label use of BMP/INFUSE in spine surgery has been linked to serious adverse events, including dysphagia, hematoma, and the need for intubation, as warned by the FDA in 2008.

Recent studies have highlighted that adverse events such as heterotopic ossification, infection, and retrograde ejaculation are under-reported, indicating significant perioperative and postoperative risks associated with BMP/INFUSE in spinal fusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. Epstein, NE.[2022]

In a study of 32 patients undergoing lumbar posterolateral fusion with PolyBone®, a beta-tricalcium phosphate synthetic graft, significant reductions in back and leg pain were observed over 12 months, with NRS scores dropping from 8.0 to 1.0 for leg pain and from 6.7 to 1.7 for back pain.

The fusion success rate was high, with 83.3% of patients achieving stage IV fusion bridges at 12 months, indicating that PolyBone® can effectively replace autologous bone grafts while minimizing donor site morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic Analysis of Instrumented Posterolateral Fusion Mass Using Mixture of Local Autologous Bone and b-TCP (PolyBone®) in a Lumbar Spinal Fusion Surgery. Park, JH., Choi, CG., Jeon, SR., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05280067

zetamet™ bone graft in the repair of bone defects from ... ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, ...

2. zetagen.com zetagen.com/research-overview/clinical-trials/

Canadian Clinical Trial for Metastatic Breast Cancer ZetaMet (Zeta-BC-003) resolves metastatic breast cancer bones lesions suspending cancer, inhibiting pain while regenerating bone, with the potential to ...

3. trialx.com trialx.com/clinical-trials/listings/222397/evaluating-zetamet-via-outpatient-local-intratumoral-injection-procedure-to-treat-breast-cancer-bone-metastases-in-the-spine-to-control-pain-and-prevent-complications-such-as-fracture/

Evaluating ZetaMet Via Outpatient Local Intratumoral ... ZetaMet™ (ZetaFuse™ Bone Graft) is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement ...

4. withpower.com withpower.com/trial/phase-metastatic-breast-cancer-in-the-spine-3-2022-e3d97

ZetaFuse™ Bone Graft for Spinal Repair in Breast Cancer The ZetaMet™ Bone Graft, which is similar to ZetaFuse™, has shown promise in reducing pain and improving quality of life in a breast cancer patient with bone ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37795710/

Treating bone metastases with local therapy in a breast ... The ZetaMet™ Bone Graft is a novel antitumorigenic and osteoinductive graft that offers a potential alternative treatment option. ZetaMet is ...

6. ctv.veeva.com ctv.veeva.com/study/zetafuse-bone-graft-in-the-repair-of-bone-defects-from-metastatic-breast-cancer-in-the-spinal-verte

ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE ... ZetaMet™ (ZetaFuse™ Bone Graft) is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without ...

7. zetagen.com zetagen.com/wp-content/uploads/2024/07/ZetaFuse-Feasibility-Study-Brochure.pdf

ZetaFuse Feasibility Study Brochure_DRAFT FOR ... ZetaFuse® is placed into the vertebral body defect created by metastatic breast cancer, via a well- established outpatient procedure called a vertebroplasty.