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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,564,006 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,750 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Sirtex MedicalIndustry Sponsor
28 Previous Clinical Trials
4,270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count should be at least 50,000 per microliter, and you should not have received a blood transfusion within the past 7 days before the study starts.Your blood takes a normal amount of time to clot.You have had chemotherapy within 2 weeks before the study, or you have not fully recovered from side effects of previous treatments.You have had any previous surgery or therapy specifically targeting the liver for metastatic breast cancer.Your liver enzymes (AST and ALT) levels are not more than 5 times the normal limit.You have HER2-positive breast cancer, no matter your hormone receptor status.The size of the tumor in the liver is less than or equal to 50%.A scan of your liver shows that it is working normally.If you have brain metastasis, it must have stayed the same for the past 6 months.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).Your white blood cell count is at least 1,000 per microliter without needing extra treatment in the last week.You have metastatic breast cancer in the liver or specific types of breast cancer based on hormone and HER2 receptor testing.Your white blood cell count must be at least 1500/uL without needing any special medication or blood transfusions for at least 7 days.The doctor thinks you will live for at least 12 more weeks.You have cancer that has spread outside of the liver, except in certain specific situations.You do not have any signs of cirrhosis in your tests or medical history.Your kidney function is good, with a creatinine level below 2 mg/dL or a glomerular filtration rate above 40 mL/min within the last 28 days.Your lipase and amylase levels should be no more than 1.5 times the upper limit of normal within 28 days before starting the treatment.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.Your bilirubin levels must be within the normal range set by the hospital.Your hemoglobin level is at least 8.0 grams per deciliter within 28 days of starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (systemic therapy, Y90 radioembolization)
- Group 2: Arm II (systemic therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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