Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

Trial Title: Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

NCT ID: NCT06142344

Condition: Liver Metastases
Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Liver metastatic breast cancer
Holmium-166
Radioembolization
TARE
SIRT
Selective internal radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Quiremspheres™
Description: 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.
Arm group label: Ho-166 radioembolization

Other name: Radioembolization with Quiremspheres™

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.

Criteria for eligibility:
Criteria:
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)

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Geert Maleux, MD, Prof

Facility:
Name: Netherlands Cancer Institute

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Status: Recruiting

Contact:
Last name: Elizabeth G Klompenhouwer, MD, PhD
Email: holibreast@nki.nl

Start date: October 19, 2023

Completion date: January 19, 2026

Lead sponsor:
Agency: The Netherlands Cancer Institute
Agency class: Other

Collaborator:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Source: The Netherlands Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06142344