Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

Breast Cancer Clinical Trial

— HoLiBreast  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142344
• Other study ID #: M21RTA
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: January 19, 2026

Study information

• Verified date: November 2023
• Source: The Netherlands Cancer Institute
• Contact: Elisabeth G Klompenhouwer, MD, PhD
• Phone: +31205129111
• Email: holibreast[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: January 19, 2026
• Est. primary completion date: October 19, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liver Metastases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Universitaire Ziekenhuizen KU Leuven

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

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