METASTATIC BREAST CANCER MedDRA version: 6.1 Level: PT Classification code 10055113
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: METASTATIC BREAS CANCER ONE LESION MEASURABLE FOR RECIST CRITERIA ADJUVANT CHEMOTHERAPY ENDED MORE THAN 12 MONTHS BEFORE PROGRESSION 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: PREVIOUS CHEMOTHERAPY FOR ADVANCED DISEASE PREVIOUS THERAPY WITH VINORELBINE PREVIOUS SECOND AND THIRD LINE HORMONOTHERAPY FOR ADVANCED DISEASE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ACTIVITY;Secondary Objective: TOXICITY TIME TO PROGRESSION OVERALL SURVIVAL;Primary end point(s): RESPONSE RATE EVALUATED WITH RECIST CRITERIA | — |
Countries
Italy