Prospective, monocentre phase I study of sequential infusion of Y90-labeled microspheres and Mitomycine C in patients with chemorefractory liver metastases from breast carcinoma

• Conditions: chemorefractory liver metastases from breast carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000454-58-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-22
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Histologically confirmed diagnosis of breast cancer
Radiological evidence of liver metastases
Liver-only or liver predominant disease
Progressive under (multi-line) systemic chemotherapy
Progressive under hormonotherapy for hor+ patients.
Patients scheduled for mitomycine chemoinfusion
Liver/lung shunt < 20% as determined by the Tc99-scan
Age older than 18 years
Karnovski >=70
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

. Karnovsky < 70
. Biochemical evidence of severe haematological toxicity and liver function test disturbances (Bilirubine > 1.5; AST/ALT > 2.5 fold normal range; Creatinine > 1.2 upper normal limit; GFR (glomerular filtration rate) < 60)
. Neutrophiles < 1000/ml
. Thrombocytes < 100.000
. Liver/lung shunt > 20% as determined by the Tc99-scan
. Allergy to contrast media
. Intake of oral anticoagulation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified