Suspended

HoLiBreastThe Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients

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What is being tested

Quiremspheres™

Device
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorThe Netherlands Cancer Institute
Study ContactElisabeth G Klompenhouwer, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 19, 2023

Actual date on which the first participant was enrolled.

This study aims to explore whether adding a special treatment called Ho-166 radioembolization to regular chemotherapy can be beneficial for patients with breast cancer that has spread to the liver. Ho-166 radioembolization is a technique that delivers radiation directly to liver tumors. The study focuses on patients with liver metastases from breast cancer, and it aims to see if this combination treatment can improve outcomes for them. This research is important because finding more effective treatments could significantly enhance the quality of life and survival rates for these patients. Participants in this study will first undergo a procedure called mapping angiography, which helps doctors visualize the blood vessels in the liver. Following this, they will receive the Ho-166 radioembolization treatment. Before this treatment, chemotherapy is paused for a few days and is then evaluated two weeks afterwards to determine if it should continue. The study will assess the feasibility and safety of this approach, monitoring how well patients tolerate the treatment and its effects on their cancer.

Official TitleThe Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
NCT06142344
Principal SponsorThe Netherlands Cancer Institute
Study ContactElisabeth G Klompenhouwer, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

9 inclusion criteria required to participate
Women >18 years
Patients with hormone positive and HER2 negative liver metastatic breast cancer
No extra-hepatic disease progression at evaluation of at least second line systemic chemotherapy
Suitable for TARE evaluated after the mapping angiography
Show More Criteria
17 exclusion criteria prevent from participating
Life expectancy ≤3 months
Patient eligible for other curative local liver therapy (ea. surgery, ablation)
Brain, pleural, peritoneal or extensive extra-hepatic visceral metastases
Other life-threatening disease (i.e. Dialysis, unresolved diarrhea, serious unresolved infections (HIV, HBV, HCV etc.))
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients will undergo standard procedures for holmium radioembolization

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Netherlands Cancer Institute

Amsterdam, NetherlandsOpen Netherlands Cancer Institute in Google Maps
Recruiting soon

University Hospital Leuven

Leuven, Belgium
Suspended2 Study Centers