Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

Inclusion Criteria:

• The subject has given written, informed consent and is available for the entire study.
• Histologically or cytologically confirmed diagnosis of breast cancer;
• Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
• Age 18 years or more

Exclusion Criteria:

• Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
• Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
• Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
• Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study