OncoMatch

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.

Phase 1/2RecruitingFudan UniversityNCT04947280Data as of May 2026

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 qualify

Extracted 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.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify