Breast Cancer, Liver Metastases
Conditions
Keywords
Liver metastatic breast cancer, Holmium-166, Radioembolization, TARE, SIRT, Selective internal radiotherapy
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.
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | Up to 3 months after intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Lesion- and patient-based response | Up to 3 months after intervention | Radiological response on contrast-enhanced CT and MRI measured by RECIST |
| Overall toxicity associated with study intervention | Up to 3 months after intervention | Graded by CTCAE/SIR grade |
| Quality of Life during study | From start inclusion to 3 months after intervention | Obtained by EORTC QLQ-C30 questionnaire |
Countries
Belgium, Netherlands
Contacts
Primary ContactElisabeth G Klompenhouwer, MD, PhD
Outcome results
None listed