Capecitabine and bevacizumab ± vinorelbine as 1st line treatment in HER2/neu-negative metastatic or locally advanced inoperable breast cancer patients
- Conditions
- HER-2/neu negative metastatic or locally advanced inoperable breast cancerMedDRA version: 17.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-003779-37-DE
- Lead Sponsor
- iOMEDICO AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
-Histologically or cytologically confirmed HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy
-effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug
- Adequate hepatic and renal function
- Adequate hematologic function
- Written informed consent
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
- contra-indication against Capecitabine, Bevacizumab or Vinorelbin
- Previous chemotherapy or previous bevacizumab-therapy for metastatic or locally recurrent breast cancer
-Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Pregnant or lactating women
- Participation in other clinical trials within 4 weeks prior to randomization
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