← Back to Search

Radiotherapy

Radioembolization for Breast Cancer Spread to Liver

Phase 2
Waitlist Available
Led By Nima Kokabi
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy proven metastatic breast cancer to the liver (liver biopsy including routine genetic profiling) if not performed before, the biopsy will be performed at the time of shunt of study/mapping
Tumor burden =< 50% of liver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial is testing radioembolization with yttrium Y-90 to see if it can effectively treat patients with breast cancer that has spread to the liver.

Who is the study for?
This trial is for adults with breast cancer that has spread to the liver and are seeking a 2nd or 3rd line therapy. They must have adequate blood counts, normal liver function, no cirrhosis, and be able to use contraception. Pregnant women or those with certain types of breast cancer (HER2+), recent treatments, or severe health issues cannot participate.Check my eligibility
What is being tested?
The study tests Y-90 radioembolization as a treatment for metastatic breast cancer in the liver. This involves injecting radioactive particles into an artery leading to the liver tumors to block their blood supply. The effectiveness and safety compared to systemic therapies will be evaluated.See study design
What are the potential side effects?
Potential side effects include abdominal pain, nausea, fatigue, fever shortly after treatment (post-embolization syndrome), potential damage to healthy liver tissue which could lead to liver failure, radiation risks like skin irritation at injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have breast cancer that has spread to the liver, and if a liver biopsy has not been done before, it will be done as part of the study.
Select...
The size of the tumor in the liver is less than or equal to 50%.
Select...
You are able to carry out all normal activities without any restrictions (ECOG performance status 0) or you are restricted in physically strenuous activity but are able to carry out work of a light or sedentary nature (ECOG performance status 1).
Select...
If you have brain metastasis, it must have stayed the same for the past 6 months.
Select...
You have metastatic breast cancer in the liver or specific types of breast cancer based on hormone and HER2 receptor testing.
Select...
The doctor thinks you will live for at least 12 more weeks.
Select...
You do not have any signs of cirrhosis in your tests or medical history.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Liver and overall progression free survival (PFS)
Secondary outcome measures
Liver progression free survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (systemic therapy, Y90 radioembolization)Experimental Treatment3 Interventions
Patients receive systemic therapy. Beginning 1-6 weeks after starting systemic therapy, patients also undergo Y90 radioembolization.
Group II: Arm II (systemic therapy)Active Control1 Intervention
Patients receive systemic therapy.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,626 Previous Clinical Trials
2,560,707 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,275 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Sirtex MedicalIndustry Sponsor
28 Previous Clinical Trials
4,270 Total Patients Enrolled

Media Library

Yttrium Y-90 (Radiotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05315687 — Phase 2
Breast Cancer Research Study Groups: Arm I (systemic therapy, Y90 radioembolization), Arm II (systemic therapy)
Breast Cancer Clinical Trial 2023: Yttrium Y-90 Highlights & Side Effects. Trial Name: NCT05315687 — Phase 2
Yttrium Y-90 (Radiotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05315687 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Systemic Therapy as a viable treatment option?

"Our team has assessed the safety of Systemic Therapy to be a 2, since this is only at Phase 2 and thus far there are limited data points confirming its efficacy."

Answered by AI

Is this medical study open to enrolling new participants?

"As per the clinicaltrials.gov database, this medical trial is not presently accepting patients - though it was initially posted on December 1st 2022 and last updated October 14th of that same year. Nevertheless, there are currently 4567 other studies actively looking for participants to join their trials.."

Answered by AI
~0 spots leftby Jul 2025