THE ADDED VALUE OF 166HO TRANS-ARTERIAL RADIOEMBOLIZATION TO SYSTEMIC THERAPY IN LIVER METASTATIC BREAST CANCER PATIENTS

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 7

Inclusion Criteria

• Women >18 years
• Patients with hormone positive and HER2 negative liver metastatic breast
cancer
• No extra-hepatic disease progression at the first 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 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) or 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We expect that this treatment strategy of TARE and systemic chemotherapy is<br /><br>feasible if 85% of the included patients safely received the combination<br /><br>therapy. Safety is defined as the percentage of the 90 day<br /><br>post-radioembolization toxicity (CTCAE/SIR grade 3 or higher) which leads to<br /><br>discontinuation of the current systemic chemotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will collect data that might be associated with lesion- and patient-based<br /><br>response, overall toxicity and quality of life. These data can be used to<br /><br>improved future study protocols. </p><br>