Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
Summary
This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherSurveys
Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.
- RadiationStereotactic Body Radiation Therapy (SBRT)
Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
- ProcedureComputed Tomography
Undergo CT, MRI and/or PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo CT, MRI and/or PET/CT
- ProcedurePositron Emission Tomography
Undergo CT, MRI and/or PET/CT
Outcome measures
Primary
Freedom from a change in systemic therapy (FCST) - overall
FCST is defined as no change in systemic therapy at 6 months after radiotherapy and patient survival at 6 months after radiotherapy. Treatment failure would indicate that there is no longer stability of systemic therapy (and thereby requires a change in systemic therapy to a different agent).
Time frame: 6 months
Secondary
Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A)
Time frame: 6 months
Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B)
Time frame: 6 months
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Quality of life - EQ-5D-5L
Time frame: Up to 5 years
Determine the local control of irradiated, oligoprogressive lesions
Time frame: Up to 5 years
Eligibility criteria
Study locations (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Rochester
Rochester, Minnesota, 55905