Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients
NCT ID: NCT06142344
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13 participants
INTERVENTIONAL
2023-10-19
2026-01-19
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ho-166 radioembolization
Patients will undergo standard procedures for holmium radioembolization
Quiremspheres™
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.
Interventions
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Quiremspheres™
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
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Locations
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University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Geert Maleux, MD, Prof
Role: primary
Other Identifiers
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M21RTA
Identifier Type: -
Identifier Source: org_study_id