Metastatic breast cancer pretreated MedDRA version: 6.1 Level: PT Classification code 10055113
Conditions
Sponsors
AZIENDA USL DI FORLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically proven breast carcinoma with metastatic or locally advanced disease. Any estrogen or progesterone receptor status. Prior chemotherapy for metastatic disease. At least a 4-week interval between the last dose of chemotherapy and study entry. Recovery from all prior treatment-related toxicities to CTC grade 1 except alopecia . 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: Unstable angina, myocardial infarction, or congestive heart failure in the last six months. Serious active infection at the time of study entry or other serious underlying medical conditions which would impair the ability of the patient to receive protocol treatment. Patients who have never received prior chemotherapy for metastatic breast cancer. Previous chemotherapy with total dose of doxorubicin 300 mg/m2 or epirubicin 450 mg/m2. Need for concomitant radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Definition of DLT, MTD and recommended dose of Liposomal Doxorubicin and Capecitabine in the treatment of metastatic breast cancer;Main Objective: Definition of DLT, MTD and recommended dose of Liposomal Doxorubicin and Capecitabine in the treatment of metastatic breast cancer;Secondary Objective: To describe the overall response rate CR PR of treated patients according to RECIST criteria and to assess safety and tolerability, especially referring to the cardiotoxicity, of the drugs combination. | — |
Countries
Italy
Outcome results
None listed