Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients (HoLiBreast)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Liver Metastases
• Intervention / Treatment: Device: Quiremspheres™

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth G Klompenhouwer, MD, PhD; Phone Number: +31205129111; Email: holibreast@nki.nl

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Not yet recruiting
      • University Hospital Leuven
      • Contact: Geert Maleux, MD, Prof
• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1066 CX
      • Recruiting
      • Netherlands Cancer Institute
      • Contact: Elizabeth G Klompenhouwer, MD, PhD; Email: holibreast@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): October 19, 2025
• Study Completion (Estimated): January 19, 2026

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: SIRT; Radioembolization; Holmium-166; TARE; Liver metastatic breast cancer; Selective internal radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: M21RTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No