Radioembolization of Metastatic Breast Cancer to the Liver as a 2nd/3rd Line Therapy

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT05315687
Trial Phases:	Phase II	Protocol IDs:	RAD5251-21 (primary) NCI-2021-03144 STUDY00002373
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05315687

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.