A randomized phase II study to assess the activity and tolerability of two regimens of metronomic oral chemotherapy methotrexate plus cyclophosphamide and cyclophosphamide plus capecitabine combined with bevacizumab in advanced breast cancer - ND
- Conditions
- ocally advanced inoperable or metastatic breast carcinomaMedDRA version: 6.1Level: PTClassification code 10057654
- Registration Number
- EUCTR2005-005046-39-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 92
Pre- or post-menopausal women with histologically proven, locally advanced inoperable or metastatic breast carcinoma. Measurable disease, defined as at least one lesion that can be accurately measured No more than 3 previous lines of chemotherapy for advanced disease.
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
Presence of cerebral or leptomeningeal involvement. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.
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