Combined Immunotherapies in Metastatic ER+ Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
Weill Medical College of Cornell University
102 participants
Nov 12, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.
Locations(3)
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NCT04563507