This phase II trial studies the effects of radioembolization with yttrium Y-90 works as a 2nd or 3rd line therapy for treating patients with breast cancer that has spread to the liver (metastatic to the liver). Yttrium Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by assessing progression free survival (PFS). SECONDARY OBJECTIVES: I. To evaluate the safety of Y90 radioembolization as a 2nd or 3rd line therapeutic option in conjunction with systemic therapy by evaluating treatment related toxicities and identifying baseline predictors of treatment related toxicity. II. To evaluate the impact of tumor biology i.e. triple negative breast cancer (TNBC) versus (vs.) non-TNBC on PFS and toxicity. III. To evaluate quality of life (QOL) changes in patients receiving Y90 versus others. IV. To evaluate the survival (OS) benefit of addition of Y90 radioembolization to systemic therapy. V. To evaluate compare inflammatory changes in the in the targeted tumors before and after Y90 radioembolization for identification of potential synergistic immunotherapy pathways. VI. To identify genetic biomarkers of treatment response to Y90 radioembolization. VII. Evaluation of efficacy and accuracy of hepatobiliary iminodiacetic acid (HIDA) scan as a tool to objectively quantify baseline and post treatment hepatic dysfunction. VIII. Evaluating timing of Y90 relative to lines of therapies already utilized and disease course. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization. ARM II: Patients receive systemic therapy. After completion of study treatment, patients are followed up at 4-8 weeks, and then every 12-16 weeks for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Y-90 SIR-Spheres
Undergo Y90 radioembolization
Systemic Therapy
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Liver and overall progression free survival (PFS)
Progression of disease is defined objectively by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using magnetic resonance imaging (MRI) or computed tomography (CT) and/or by positron emission tomography (PET) using PET Response Criteria in Solid Tumors (PERCIST) criteria. PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Time frame: From date of randomization to date of progression or death, where those alive without progression are censored at date of last imaging scan, assessed up to 24 months
Liver progression free survival (PFS)
Liver progression is defined as progression of disease in the liver only by RECIST 1.1 or PERCIST criteria. Liver PFS will be estimated using the Kaplan-Meier method, and treatment groups will be compared using log-rank tests. Median liver PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Time frame: From date of randomization to date of liver progression or death, where those alive without liver progression are censored at date of last imaging scan, assessed up to 24 months
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