Clinical trial NCT06142344: Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients
Official title: The Added Value of 166Ho Trans-arterial Radioembolization to Systemic Therapy in Liver Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Metastases
Breast Cancer
Keywords: Liver metastatic breast cancer
Holmium-166
Radioembolization
TARE
SIRT
Selective internal radiotherapy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2023-11-21
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Feasibility
timeFrame: Up to 3 months after intervention
Secondary outcomes:
measure: Lesion- and patient-based response
timeFrame: Up to 3 months after intervention
measure: Overall toxicity associated with study intervention
timeFrame: Up to 3 months after intervention
measure: Quality of Life during study
timeFrame: From start inclusion to 3 months after intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord Holland
Study officials:
References: