Phase II study evaluating efficacy and tolerability of Sorafenib in the treatment of iatrogenic lymphedema occurring in breast cancer patients following surgical dissection of, and/or radiotherapy on axillary lymphnodes - ND

• Conditions: Breast cancer patients; MedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm

• Registration Number: EUCTR2009-009418-42-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-04
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

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

Inclusion Criteria

Patients with breast cancer following surgical dissection of, and/or radiotherapy on axillary lymphnodes Acquired arm lymphedema occurring following surgical dissection of, and/or radiotherapy on axillary lymphnodes Histologically confirmed diagnosis of breast cancer Age ≥18 years ECOG Performance Status of 0 or 1 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. History of allergic reactions attributed to sorafenib Patients with evidence or history of bleeding diathesis. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial. Patients receiving oral anticoagulants or low molecular weight heparin

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Sorafenib in the treatment of iatrogenic lymphedema occurring in breast cancer patients following surgical dissection of, and/or radiotherapy on axillary lymphnodes;Secondary Objective: To evaluate safety and tolerability of Sorafenib when administered at low dose;Primary end point(s): Reduction of lymphedema measured as percentage reduction of arm diameter as compared to baseline Evaluation of arm functional recovery