Transarterial Chemoembolization with Drug-Eluting BeadsLoaded with Doxorubicin for the Treatment of MetastaticBreast Cancer to the Liver: a pilot study

Not provided0 sitesJune 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

June 13, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Not provided

•Patients with biopsy proven liver dominant ( over 50% volume) metastasis of breast carcinoma
•Patients with at least one measurable liver tumor, with size \> 1cm (modified RECIST criteria)
•Hematologic function: ANC ? 1\.5 x 109/L, platelets ? 75 x109/L, INR \<1\.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti\-coagulation prior to intervention
•Adequate liver function as measured by: Total bilirubin \= 2\.0 mg/dl
•Adequate renal function (creatinine \= 2\.3 mg/dl)
•written informed consent
•over 18 years of age
•eligible for treatment
•non pregnant
•using an acceptable contraceptive if premenopausal.

•contraindication to angiographic and selective visceral catheterization
•significant extrahepatic disease representing an eminent life\-threatening outcome : more than 75% of hepatic parenchymal involvement
•severe liver dysfunction
•and severe cardiac comorbidities.
•Active bacterial, viral or fungal infection within 72 hours of study entry
•Women who are pregnant or breast feeding
•?ECOG Performance Status score of \>3
•?Life expectancy of \< 3 months
•Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated
•Any contraindication for hepatic embolization procedures: