Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer

Key Inclusion Criteria:

* Written informed consent.
* Able to comply with the protocol.
* ECOG Performance status 0 - 2.
* Life expectancy more than 12 weeks.
* Known ER / PR status.
* Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
* Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
* Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
* No signs and symptoms of CHF.
* Adequate hepatic and renal function values.
* Adequate hematologic function values.

Key Exclusion Criteria:

* Pregnant or lactating females.
* Previous chemotherapy for metastatic or locally recurrent breast cancer.
* Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
* Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
* Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
* Active infection requiring i.v. antibiotics at randomization.
* Clinically significant malabsorption syndrome or inability to take oral medication.
* Known hypersensitivity to any of the study drugs or excipients.
* Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.