Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer

Inclusion Criteria:

* Female subjects with triple negative metastatic breast cancer, age 18 years or older, pathologically confirmed metastatic adenocarcinoma of the breast. Pathologically confirmed as triple-negative, measurable disease, defined by (RECIST 1.1) guidelines;
* Two or more prior chemotherapy, immunotherapy and/or monoclonal antibody therapy for the treatment of the subjects' metastatic breast cancer;
* Prior neoadjuvant or adjuvant chemotherapy must have been completed at least 4 weeks before start of study treatment with all related toxicities resolved;
* Prior radiotherapy must have completed at least 2 weeks before randomization, with full recovery;
* At least 4 weeks from major surgery, ECOG performance status 0-1.
* Hematology parameters (ANC) ≥ 1500/mm2;
* Platelets ≥ 100,000/mm2;
* Hemoglobin (Hgb) ≥ 9 g/dL AST \& ALT ≤ 2.5 x ULN);
* If hepatic metastases present ≤ 5.0 x ULN Total bilirubin ≤ ULN ;
* Subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN;
* Alkaline phosphatase ≤ 2.5 x ULN (unless bone metastases are present in the absence of liver metastasis);
* Creatinine clearance \> 60 mL/min

Exclusion Criteria:

* Male subjects with triple negative metastatic breast cancer;
* Concurrent chemotherapy, immunotherapy or monoclonal antibody or any other anti-tumor therapy for breast cancer,
* Concurrent or prior anticoagulation therapy within 7 days of first dose of study treatment,
* History of, or known current evidence of brain metastasis, including leptomeningeal involvement;
* Subjects with bone as the only site of metastatic disease.