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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009418-42-IT
Enrollment
32
Registered
2009-05-04
Start date
2009-05-19
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients MedDRA version: 9.1 Level: LLT Classification code 10006279 Term: Breast neoplasm

Interventions

Trade Name: NEXAVAR Pharmaceutical Form: Coated tablet INN or Proposed INN: Sorafenib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Sponsors

ISTITUTO NAZIONALE PER LA CURA TUMORI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026