Using targeted radiation therapy for breast cancer bone metastases

Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer

This study is testing a new type of targeted radiation therapy for people with breast cancer that has spread to their bones to see if it can help them feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04947280 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of fractionated stereotactic radiation therapy (FSRT) in treating bone metastases in patients with breast cancer. Eligible participants will receive FSRT, which delivers high doses of radiation precisely to the tumor while minimizing damage to surrounding healthy tissue. The treatment regimen involves either 9-10 Gy for three fractions or 6-7 Gy for five fractions, guided by imaging techniques. The goal is to determine if this approach can improve outcomes for patients with metastatic spinal tumors.

Who should consider this trial

Good fit: Ideal candidates include patients with invasive breast cancer who have confirmed bone metastases and meet specific health criteria.

Not a fit: Patients with tumors too close to the spinal cord or those who have not failed previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less harmful option for patients with breast cancer that has spread to the bones.

How similar studies have performed: Other studies have shown promising results with similar radiation therapy approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of invasive breast cancer
2. Signed informed consent
3. Bone metastases (confirmed by MRI within 4 weeks of enrollment).
4. Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
5. KPS ≥ 40 or ECOG 0-2.
6. The tumor is at least 2 mm away from the spinal cord. If the tumor is closer than 2 mm, surgical resection is required prior to FSRT or the total prescription dose of spinal cord is strictly limited.
7. Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
8. A maximum of three distinct noncontiguous spinal metastases per patient was allowed, and each of the separate sites may have involvement of 2 contiguous vertebral bodies.
9. Patients have sufficient bone marrow reserve and liver and kidney function: neutrophil count ≥ 1500 cells / mm3; platelet count ≥ 70000 / mm3; hemoglobin (Hgb) ≥ 8.0 g / dl; if there is liver metastasis, AST and ALT \< 3x ULN
10. The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment ≤ grade 1
11. Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included

Exclusion Criteria:

1. Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with \> 50% loss of vertebral body height were excluded.
2. Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
3. Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
4. Patients who had a history of previous radiotherapy to the spine at the current level of interest.
5. Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
6. Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.
7. Patients who had received chemotherapy within 2 weeks of starting protocol treatment.
8. Patients who are unwilling or unable to receive regular follow-up.
9. The patients judged by the researchers who could not be included in some special cases.
10. Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.
11. Pregnant women.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhaozhi Yang, MD, Ph.D — Fudan University
• Study coordinator: Zhaozhi Yang, MD, Ph.D

Conditions Bone Metastases; Breast Cancer