A phase II randomised study to investigate the effects of Bevacizumab on cell proliferation and on pCR in patients with locally advanced operable breast cancer - ND
- Conditions
- histologically proven primary breast cancer 2.0 cm, T2-T3 T4 a-d, N0-2, M0MedDRA version: 6.1Level: PTClassification code 10057654
- Registration Number
- EUCTR2005-005048-19-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 120
Patients with histologically proven primary breast cancer 2.0 cm, T2-T3 T4 a-d, N0-2, M0 Women aged 18 70 years
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
Patients with overexpression HER2/neu 3 or amplification of HER2/neu gene evaluated by FISH, suitable for Herceptin containing regimens as primary therapy Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV INR greater than 1.50. Prior history of bleeding diathesis or coagulopathy including deep venous thrombosis or pulmonary embolism. Recent within last six months or current history of gastrointestinal bleeding.
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