HoLiBreast: Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

Sponsor

The Netherlands Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06142344

Collaborator

Universitaire Ziekenhuizen KU Leuven (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

6.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Metastases Breast Cancer	Device: Quiremspheres™	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 19, 2023

Anticipated Primary Completion Date :

Oct 19, 2025

Anticipated Study Completion Date :

Jan 19, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ho-166 radioembolization Patients will undergo standard procedures for holmium radioembolization	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. Other Names: Radioembolization with Quiremspheres™

Arm

Intervention/Treatment

Experimental: Ho-166 radioembolization

Patients will undergo standard procedures for holmium radioembolization

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.

Other Names:

Radioembolization with Quiremspheres™

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)