OncoMatch/Clinical Trials/NCT04947280
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
Is NCT04947280 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for bone metastases.
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Metastatic disease required
Performance status
KPS/ECOG 40–2
KPS ≥ 40 or ECOG 0-2
Prior therapy
Must have received: external beam radiotherapy or surgery — bone metastases
Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
Cannot have received: radiotherapy to the spine at the current level
history of previous radiotherapy to the spine at the current level of interest
Cannot have received: external-beam irradiation to the spine
prior external-beam irradiation to the spine within 3 months of registration
Cannot have received: systemic radiotherapy (Strontium-89)
systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment
Cannot have received: chemotherapy
chemotherapy within 2 weeks of starting protocol treatment
Lab requirements
Blood counts
neutrophil count ≥ 1500 cells / mm3; platelet count ≥ 70000 / mm3; hemoglobin (Hgb) ≥ 8.0 g / dl
Kidney function
sufficient kidney function
Liver function
if there is liver metastasis, AST and ALT < 3x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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