Dose finding study of Liposomal Doxorubicin Myocet in combination with Capecitabine Xeloda in the treatment of metastatic breast cancer patients - ND
- Conditions
- Metastatic breast cancer pretreatedMedDRA version: 6.1Level: PTClassification code 10055113
- Registration Number
- EUCTR2005-005885-36-IT
- Lead Sponsor
- AZIENDA USL DI FORLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method