Advanced breast cancer MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically proven diagnosis breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. At least one bidimensionally measurable lesion adequately measured by imaging procedure (See section 15). Prior chemotherapy 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: Patient with T4d disease inflammatory cancer as unique disease, symptomatic lung lymphangitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the Disease Control Rate;Secondary Objective: safety profile of treatment, the role of biomarkers of angiogenesis (soluble VEGF, VEGFr2, TSP1, bFGF and circulating progenitor endothelial cells) as a surrogate markers of response;Primary end point(s): Disease Control Rate (PR+CR + SD > 6 months) | — |
Countries
Italy
Outcome results
None listed