Clinical trial · Interventional
Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients
The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
NCT06142344CI-TRIAL-00071535HoLiBreastunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quiremspheres™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ho-166 radioembolization
- description
- Patients will undergo standard procedures for holmium radioembolization
- interventionNames
- Device: Quiremspheres™
Primary outcomes (1)
- measure
- Feasibility
- timeFrame
- Up to 3 months after intervention
- description
- 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.
Secondary outcomes (3)
- measure
- Lesion- and patient-based response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.