SBRT for Breast Cancer Oligometastases

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    50
  • sponsor
    King Hussein Cancer Center
Updated on 24 January 2021
cancer
breast cancer

Summary

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
Treatment Stereotactic body radiotherapy
Clinical Study IdentifierNCT04424732
SponsorKing Hussein Cancer Center
Last Modified on24 January 2021

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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