Patients with breast carcinoma and liver-dominant metastasis
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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: - Large shunt as determined by the investigator (pretesting with TcMMA not required) - Severe atheromatosis vascular disease that precludes arterial cannulization - Hepatofugal blood flow - Main portal vein occlusion (e.g. thrombus or tumor) • Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation • Patients with prior contraindications for the use of doxorubicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intra-arterial hepatic doxorubicin therapy in Metastatic Breast Cancer. The primary objective of this study is to determine the safety, feasibility, and tolerance of intra-arterial doxorubicin-loaded microsphere treatment. ;Secondary Objective: The secondary objective will be to evaluate the response rate , time to progression and survival.;Primary end point(s): Technical feasibility of the treatment protocol, including: adequate pain relief during the procedure, the loading of beads, angiographic success and procedure-related toxicity ( defined as procedure related complications that makes hospitalisation longer than 48 hours post-procedure necessary. Proportion of patients completing scheduled treatment plan. ;Timepoint(s) of evaluation of this end point: 1 day, 30 days, every three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate ( according to RECIST), time to progression, and overall survival .;Timepoint(s) of evaluation of this end point: every three months | — |
Countries
Netherlands
Outcome results
None listed