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RecruitingNCT06142344HoLiBreastUpdated Nov 21, 2023

Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

An interventional study of Quiremspheres™ in Liver Metastases and Breast Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Liver Metastases
  • Breast Cancer

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Keywords

  • Liver metastatic breast cancer
  • Holmium-166
  • Radioembolization
  • TARE
  • SIRT
  • Selective internal radiotherapy
03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 13 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Estimated dose to the lungs greater than 30 Gy in a single administration or 50 Gy cumulatively
  • Target tumoral absorbed dose of \< 90Gy or an absorbed dose to the normal liver parenchyma of >50Gy (in case of whole liver treatment)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    Ho-166 radioembolization

    Patients will undergo standard procedures for holmium radioembolization

    Device: Quiremspheres™

Interventions

  • DeviceQuiremspheres™

    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™

06

What researchers measure

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.

    Time frame: Up to 3 months after intervention

Secondary outcomes

  1. Lesion- and patient-based response

    Radiological response on contrast-enhanced CT and MRI measured by RECIST

    Time frame: Up to 3 months after intervention

  2. Overall toxicity associated with study intervention

    Graded by CTCAE/SIR grade

    Time frame: Up to 3 months after intervention

  3. Quality of Life during study

    Obtained by EORTC QLQ-C30 questionnaire

    Time frame: From start inclusion to 3 months after intervention

07

Study locations

1 of 2 sites recruiting
  • University Hospital Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
    • Geert Maleux, MD, Prof · Contact
    Not yet recruiting
  • Netherlands Cancer Institute
    Amsterdam, Noord Holland 1066 CX, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06142344
Lead sponsor
The Netherlands Cancer Institute
Collaborators
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Nov 21, 2023
Start date
Oct 19, 2023
Primary completion
Oct 19, 2025 (estimated)
Completion
Jan 19, 2026 (estimated)
Last update
Nov 21, 2023

Study contacts

Elisabeth G Klompenhouwer, MD, PhD
Contact
holibreast@nki.nl
+31205129111

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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