advancer breast carcinoma MedDRA version: 9.1 Level: LLT Classification code 10006279 Term: Breast neoplasm
Conditions
Sponsors
OSPEDALE ONCOLOGICO DI BARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven advanced breast carcinoma 2. Patients pretreated with taxanes plus/minus anthracyclines 3. Age >18 and 3 months 5. Normal cardiac function 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: 1. History of prior malignancy in the last 10 years 2. Symptomatic peripheral neuropathy 3. Other serious illness or medical condition 4. Concurrent treatment with other experimental drugs 5. ASAT (SGOT) and/or ALAT (SGPT) > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Response Rate (RR) of the combination of capecitabine with oral vinorelbina in the treatment of patients with advanced breast cancer previously submitted tochemotherapy with taxanes plus/minus anthracyclines;Secondary Objective: 1. To evaluate the safety of this combination 2. To assess the time to progression (TTP) and Overall survival (OS);Primary end point(s): To assess the efficacy of the combination of capecitabine with oral vinorelbine in advanced metastic breast cancer | — |
Countries
Italy
Outcome results
None listed