A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed diagnosis of breast cancer with locally advanced disease for which there is no surgical option, or stage IV disease.
• •ER-negative and PR-negative (defined as less than or equal to 10% tumor staining).
• •HER2-negative defined as one of the following:
• •1. 0 or 1+ IHC;
• •2. 2+ or 3+ IHC and FISH negative (ratio \< 2.2);
• •3. or FISH negative (ratio \< 2.2).
• •No less than one and no more than two prior chemotherapy regimens for advanced or metastatic disease.
• •Prior chemotherapy must have included a taxane either as part of an adjuvant regimen or as part of a metastatic disease regimen.
• •Interval from last dose of prior treatment to enrollment in this study must be at least 4 weeks for cytotoxic chemotherapy (exception: 6 weeks for nitrosoureas or mitomycin C), 5 half-lives for non-cytotoxic therapy (to be reviewed by the Medical Monitor to establish start date), and 4 weeks for monoclonal antibodies; patients must have recovered from all acute toxicities.
• •Measurable disease by RECIST.
• •ECOG performance status of 0-2.
• •Females at least 18 years of age.
• •Adequate bone marrow function as defined by absolute neutrophil count of greater than or equal to 1,500/ mm\^3 and platelets of greater than or equal to 100,000/mm\^3.
• •AST(SGOT) and ALT(SGPT) levels no greater than 3 x the institutional ULN, and total bilirubin less than or equal to 1.5 x ULN.
• •Serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) for patients with serum creatinine levels \> 1.5 x ULN.
• •Able to understand and show willingness to sign a written informed consent document.