What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those targeting bone metastases, include chemotherapy, hormonal therapy, and osteoclast inhibitors. Chemotherapy can cause side effects such as nausea, fatigue, hair loss, and increased risk of infection. Hormonal therapies, like tamoxifen and anastrozole, may lead to hot flashes, joint pain, and bone density loss. Osteoclast inhibitors, such as bisphosphonates and denosumab, are associated with risks like osteonecrosis of the jaw, hypocalcemia, and renal impairment. These treatments aim to manage symptoms and improve quality of life but come with potential adverse effects that need to be managed in collaboration with healthcare providers.

What prior FDA approvals exist?

FDA-approved treatments for metastatic breast cancer that focus on bone health and structural support include bisphosphonates like zoledronic acid and denosumab, which are used to strengthen bones and reduce skeletal-related events. Additionally, radiopharmaceuticals such as samarium-153 lexidronam provide pain relief and target bone metastases. These treatments help manage bone integrity and alleviate symptoms in patients with metastatic breast cancer affecting the vertebral body.

What other types of research exist?

Promising alternatives to ZetaFuse™ Bone Graft for breast cancer patients with vertebral body metastases include: 1) Zoledronic acid, a bisphosphonate that prevents bone loss and has shown efficacy in reducing skeletal-related events in patients with bone metastases. 2) Denosumab, a monoclonal antibody that inhibits osteoclast activity, thereby reducing bone resorption and preventing skeletal-related events. 3) Strontium ranelate, which has shown potential in reducing cartilage volume loss and bone marrow lesion progression, although primarily studied in osteoarthritis, it may offer benefits in bone metastasis management. These alternatives provide structural support and promote bone regeneration, making them viable options for consideration in 2024.

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Bone Graft

ZetaFuse™ Bone Graft for Spinal Repair in Breast Cancer (ZGMBC Trial)

N/A

Recruiting

Research Sponsored by Zetagen Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one lytic metastatic lesion located in the vertebral body of the spine

Female patient with histologically confirmed diagnosis of primary breast cancer

Must not have

Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids)

Vertebral body collapse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 up to day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the ZetaFuse™ Bone Graft, a material used to repair bone damage in the spine caused by cancer. It targets patients with breast cancer that has spread to their bones, making their spine unstable. The graft is placed into the damaged area to support and strengthen the bone. Standard care for these patients includes treatments that help maintain bone strength.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions to implant materials such as inflammation or infection at the site of implantation; interference with bone healing; and general surgical risks associated with percutaneous procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancerous lesion in the spine.

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

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I am between 22 and 75 years old.

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My spine is normally aligned.

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I have up to 5 cancer spread areas in no more than 3 different parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a spinal bone collapse.

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I have spinal cord compression.

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I have been diagnosed with diabetes.

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I do not have an active systemic infection like hepatitis or AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 up to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 up to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 up to day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational Device The ZetaFuse™ Bone GraftExperimental Treatment1 Intervention

The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormonal therapies, chemotherapy, targeted therapies, and bone-modifying agents. Hormonal therapies, such as tamoxifen and aromatase inhibitors, work by blocking estrogen receptors or decreasing estrogen production, which is crucial for hormone receptor-positive breast cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies, like HER2 inhibitors, specifically target molecular abnormalities in cancer cells, reducing damage to normal cells. Bone-modifying agents, such as bisphosphonates and denosumab, inhibit osteoclast-mediated bone resorption, helping to prevent skeletal-related events and maintain bone integrity. These treatments are vital for managing metastatic breast cancer, as they not only control tumor growth but also address complications like bone metastases, enhancing patient quality of life and outcomes.

Premenopausal women with early breast cancer treated with estradiol suppression have severely deteriorated bone microstructure.