Schedules of Nab-Paclitaxel in Metastatic Breast Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
• •Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
• •Female aged 18 years or older.
• •Life expectancy \> 3 months.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• •Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
• •If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been \> 12 months (\> 365 days).
• •Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
• •Normal hematologic status.
• •Normal renal function.
• •Normal liver function.
• •Normal cardiac function.
• •Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
• •Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
• •Completed baseline Quality of Life Form.
• •The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
• •Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
• •Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.