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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Undergo blood sample collection
Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.
Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGFreedom 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
Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A)
Will assess whether metastasis-directed radiotherapy can result in a clinically significant FCST (defined as for at least 6 months) for patients with estrogen receptor+/progesterone receptor±/human epidermal growth factor receptor 2 negative (ER+/PR±/HER2-) disease. The frequency and percentage for FCST rate will be reported, including the 95% confidence interval.
Time frame: 6 months
Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B)
Will assess whether metastasis-directed radiotherapy can result in a clinically significant FCST (defined as for at least 6 months) for patients with human epidermal growth factor receptor 2 positive (HER2+) disease. The frequency and percentage for FCST rate will be reported, including the 95% confidence interval.
Time frame: 6 months
Progression-free survival (PFS)
Will assess the impact of metastasis-directed radiotherapy on PFS in the setting of oligoprogressive breast cancer. PFS is defined as the time from completion of radiotherapy to the first of either disease progression or death from any cause. Medians and 95% confidence intervals will be reported.
Time frame: Up to 5 years
Overall survival (OS)
Will explore the impact of metastasis-directed radiotherapy on overall survival (OS) in the setting of oligoprogressive breast cancer. OS is defined as the time from completion of radiotherapy to death from any cause. Medians and 95% confidence intervals will be reported.
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Undergo CT, MRI and/or PET/CT
Undergo CT, MRI and/or PET/CT
Undergo CT, MRI and/or PET/CT
Time frame: Up to 5 years
Quality of life - EQ-5D-5L
The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a patient-reported outcome measure used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on a score of 1-5 where 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the task. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.
Time frame: Up to 5 years
Determine the local control of irradiated, oligoprogressive lesions
This rate will be reported as a percentage with a 95% confidence interval.
Time frame: Up to 5 years