Anatomic Stage IV Breast Cancer AJCC v8, Breast Carcinoma, Metastatic Breast Cancer
Conditions
Brief 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
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
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Histological confirmation of primary breast cancer. * Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy. * NOTE: patients with de novo metastatic disease and those developed metastatic disease after initially localized disease can both be included. OR * Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2. * Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. * Ability to complete questionnaire(s) by themselves or with assistance. * Provide written informed consent. * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study). * Willing to provide blood samples for correlative research purposes. * Receiving radiation therapy as specified in the protocol.
Exclusion criteria
* Male patients. * Nursing or pregnant women. * Men or women of childbearing potential who are unwilling to employ adequate contraception. * Patients with triple negative disease (negative for ER, PR, and HER2). * Active second primary malignancy * More than 3 extracranial sites of oligoprogressive disease * Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed. * Active connective tissue disease that is felt by the treatment team to pose an excess risk of toxicity. * Prior radiation that overlaps with the intended treatment volume such that, in the opinion of the patient's Radiation Oncologist, radiotherapy to progressing sites will not be safe. * NOTE: patients with some dose overlap with prior radiotherapy that is deemed safe by the patient's Radiation Oncologist can be included in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from a change in systemic therapy (FCST) - overall | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A) | 6 months | 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. |
| Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B) | 6 months | 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. |
| Progression-free survival (PFS) | Up to 5 years | 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. |
| Overall survival (OS) | Up to 5 years | 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. |
| Quality of life - EQ-5D-5L | Up to 5 years | 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. |
| Determine the local control of irradiated, oligoprogressive lesions | Up to 5 years | This rate will be reported as a percentage with a 95% confidence interval. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoman O. Kowalchuk, MD
Mayo Clinic in Rochester
Outcome results
None listed