NCT05315687

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Metastatic Carcinoma in the Liver
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

Type	Name	Description
DEVICE	Y-90 SIR-Spheres	Y-90 SIR-Spheres
PROCEDURE	Yttrium-90 Microsphere Radioembolization	Undergo Y90 radioembolization
OTHER	Systemic Therapy	Systemic Therapy

Timeline

• Start date: 2022-08-17
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2022-04-07
• Last updated: 2024-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study