SBRT for Breast Cancer Oligometastases

STATUS

Recruiting
End date

Jun 1, 2026
participants needed

50
sponsor

King Hussein Cancer Center

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Updated on 19 February 2024

See if I qualify

cancer

breast cancer

metastasis

solid tumor

bone metastases

primary tumor

solid tumors

positron emission tomography

bone scan

stereotactic body radiation therapy

sbrt

breast neoplasm malignant female

Summary

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This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.

Details

Condition	Breast Neoplasm Malignant Female
Age	18years - 100years
Treatment	Stereotactic Body Radiotherapy
Clinical Study Identifier	NCT04424732
Sponsor	King Hussein Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Women >18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included
	Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases
	Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT
	Maximum diameter of individual metastasis metastasis in any dimension 5 cm; and must be >5 cm away from each other (defined as Edge to Edge of tumor)
Exclusion Criteria
	Non bone metastatic breast cancers
	Prior history of radiotherapy to same sites of SBRT
	Pathologic fractures of involved bones
	Contraindications to radiotherapy including pregnancy and connective tissue disease
	Patients with impaired cognitive functions

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SBRT for Breast Cancer Oligometastases