Inclusion Criteria:
- female patients
- 21 years of age or older
- histologically/cytologically confirmed carcinoma of the breast
- documented locally recurrent or metastatic disease not amenable to curative surgery
or radiotherapy
- either one, two or three prior chemotherapy regimens
- prior treatments including both an anthracycline and a taxane and patient no longer
candidate for these drugs
- measurable or non-measurable disease according to RECIST 1.1
- Karnofsky performance score of at least 70 %
- adequate haematological, hepatic and renal functions
- ECG without clinically relevant abnormality
Exclusion Criteria:
- known or clinical evidence of brain metastasis or leptomeningeal involvement
- pulmonary lymphangitis or symptomatic pleural effusion
- any serious, concurrent uncontrolled medical disorder
- history of second primary malignancy
- preexisting motor/sensory peripheral neuropathy
- known history of HIV infection
- prior therapy with capecitabine and/or vinca-alkaloids
- history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or
contra indication to any of these drugs
- known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
- pregnancy or breast feeding