Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions
All patients start standard therapy with oral letrozole (Femara), day 1 of the study.
Number of subjects achieving Objective response rate (ORR) will be assessed.
ORR is defined as the percentage of subjects with either a confirmed complete response (CR) or partial response (PR).
Time frame: End of study, up to 36 months.
Number of Subjects achieving Progression free survival (PFS)
Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death.
Time frame: End of study, up to 36 months.
Number of subjects achieving Overall survival(OS) will be assessed.
OS is defined as the time from the start of treatment until death.
Time frame: End of study, up to 36 months.
Serial levels of Circulating tumor DNA (ctDNA)
serial levels ctDNA can be an early indication of progression
Time frame: End of study, up to 36 months.
Circulating tumor DNA (ctDNA) levels
Circulating tumor DNA (ctDNA) levels will be measured to determine baseline cancer heterogeneity and its response to treatment
Time frame: End of study, up to 36 months.
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Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.