Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Metastases, Breast Cancer

Intervention / Treatment
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* Device: Quiremspheres™


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ho-166 radioembolization<br>Patients will undergo standard procedures for holmium radioembolization | Device: Quiremspheres™<br>* 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.<br>* Other names: Radioembolization with Quiremspheres™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion- and patient-based response | Radiological response on contrast-enhanced CT and MRI measured by RECIST | Up to 3 months after intervention | 
| Overall toxicity associated with study intervention | Graded by CTCAE/SIR grade | Up to 3 months after intervention | 
| Quality of Life during study | Obtained by EORTC QLQ-C30 questionnaire | From start inclusion to 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver metastatic breast cancer, Holmium-166, Radioembolization, TARE, SIRT, Selective internal radiotherapy