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.

Exclusion criteria

• Any prior chemotherapy for metastatic breast cancer.
• Presence of central nervous system (CNS) metastasis.
• Peripheral neuropathy grade 2 or higher (CTCAE version 4).
• Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
• Pregnant or lactating.
• Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
• Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
• Contraindications or known hypersensitivity to the study medication or excipients.
• The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
• Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.