Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients

Exclusion Criteria

• •Disease-specific exclusions
• •Patients who have received anti-angiogenic therapy \[e.g. tyrosine kinase inhibitors (TKIs) or anti-vascular endothelial growth factors (anti-VEGFs)\] other than Bevacizumab for the first-line treatment of MBC.
• •Patients who have exclusively received endocrine treatment in combination with Bevacizumab until the first progression.
• •Positive or unknown Human Epidermal Growth Factor Receptor 2/neu status or for whom determination of Human Epidermal Growth Factor Receptor 2 status is not possible. In general, Human Epidermal Growth Factor Receptor 2 positive status will be identified by a FISH assay as evaluated at the institution, or, if FISH is unavailable, a 2+ or 3+ immunohistochemistry result (but method of identification may vary by region or institution).
• •Current, recent (within 4 weeks or 2 half-lives, whichever is greater, before day 1) or planned participation in an experimental drug study - other than a Bevacizumab breast cancer study.
• •Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix or breast within the last 5 years.
• •Any laboratory values at baseline as described in the protocol;
• •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
• •Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
• •Patients who are treated with any medicinal product that contraindicates the use of any of the study drugs, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
• •Bevacizumab-specific exclusions: (see protocol)
• •Eribulin-specific exclusions: (see protocol)