This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment.
This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Female or male
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease
Patients may not have received chemotherapy, radiation therapy, biological therapy, immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held during study therapy and can resume 7-14 days after completion of all study therapy (SBRT) at the discretion of treating physician. (Patients may continue anti-endocrine/hormone therapy before, during and after study therapy at the discretion of the treating medical oncologist.)
Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy
Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer. Prior malignancies not listed require principal investigator (PI) approval
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo PET/CT scan
F-18 16 Alpha-Fluoroestradiol
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT scan
Questionnaire Administration
Other interventionAncillary studies
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatment
Analysis will be descriptive in nature and will include the counts and percentages of patients who are responders versus (vs.) non-responders. Results will summarize groups based on intent-to treat.
Rate of all grades and grade ≥ 3 toxicities at least possibly related to study therapy
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient reported outcomes CTCAE. Descriptive statistics will be used to summarize patient and physician reported toxicity. Results will be presented by entire group and stratified by response status (responders vs. non-responders). Chi-square analyses will be used to compare responders with non-responders at each timepoint.
Number of lesions found on F-18 16 alpha fluoroestradiol positron emission tomography (FES-PET)
The number of additional lesions found on FES-PET prior to SBRT will be summarized using means, median, and ranges.
Change in quality of life (QOL)
Descriptive statistics will be used to summarize changes in QOL measured using the European Organization for research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Quality of Life Questionnaire Breast 45. Change from baseline results will be presented for the entire group as well as stratified by response status (responders vs. non-responders). Continuous data will be summarized using means and standard deviations, while categorical data will be summarized using counts and percentages. Difference across response status will be assessed using paired t-tests for continuous data and chi-square analyses for categorical data.
Time to next line of systemic therapy
The time from next line of systemic therapy summarized using means, medians, and ranges and will be based on intent-to-treat. Time to next line of systemic therapy will be calculated from the date of study entry to the first date of next line therapy using the Kaplan-Meier method.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
