NCT06142344

Brief Summary

The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer. Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Liver MetastasesBreast Cancer

Keywords

Liver metastatic breast cancerHolmium-166RadioembolizationTARESIRTSelective internal radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    The percentage of patients were radioembolization and systemic chemotherapy is safely feasible. Safety is defined as percentage of 90 day post-radioembolization (CTCAE/SIR grade 3 or higher) which lead discontinuation of the current systemic chemotherapy. Time to re-start chemotherapy after intervention in days will be collected.

    Up to 3 months after intervention

Secondary Outcomes (3)

  • Lesion- and patient-based response

    Up to 3 months after intervention

  • Overall toxicity associated with study intervention

    Up to 3 months after intervention

  • Quality of Life during study

    From start inclusion to 3 months after intervention

Study Arms (1)

Ho-166 radioembolization

EXPERIMENTAL

Patients will undergo standard procedures for holmium radioembolization

Device: Quiremspheres™

Interventions

Quiremspheres™DEVICE

The intervention comprises two steps. Initially, the patient will undergo mapping angiography and a Ho-166 scout dose. If deemed eligible, the patient will proceed to 166-Ho radioembolization.

Also known as: Radioembolization with Quiremspheres™
Ho-166 radioembolization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Measurable target tumors in the liver according to RECIST 1.1
  • Liver tumor burden \<50 %
  • ECOG performance score 0 to 1
  • Laboratory parameters: neutrophils \>1000/μL; thrombocyte count \>1000000 μL; eGFR \>45/mL/min/1.73 m2; albumin \> 3.0 g/dl, bilirubin \< 1.5x ULN (unless Gilbert syndrome); aminotransferase (ALAT/ASAT) \<3.0 ULN
  • Able to read Dutch

You may not qualify if:

  • 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.))
  • Contraindication for angiography or MRI
  • Significant toxicities due to prior cancer therapy that have not resolved before the initiation of the study, if the investigator determines that the continuing complication will compromise the safe treatment of the patient
  • Prior or planned embolic intra-arterial liver directed therapy (TACE, TAE, TARE)
  • Prior or planned external or internal radiation therapy of the liver
  • Cirrhosis or portal hypertension
  • Main portal vein thrombosis
  • Intervention for, or compromise of, the Ampulla of Vater
  • Ascites (except minor focal ascites)
  • Baseline use of analgesics for abdominal pain
  • Pregnancy (Women at childbearing potential need at least one form of birth control) and breastfeeding
  • Flow to extra hepatic vessels not correctable by reposition or embolization
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Elisabeth G Klompenhouwer, MD, PhD

CONTACT

+31205129111holibreast@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

October 19, 2023

Primary Completion

October 19, 2025

Study Completion

January 19, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)NL(1)