Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Exclusion Criteria

• •Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if \> 12 months has passed since last administration).
• •Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
• •Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
• •Radiotherapy
• •Major surgery
• •Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
• •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
• •Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
• •Patients with the following laboratory values during screening and on Day 1 predose:
• •Absolute Neutrophil Count (ANC) \< 1.5x109/L
• •Hemoglobin \< 9 g/dL
• •Platelets \< 100x109/L
• •Serum creatinine \> 1.5 x ULN
• •Serum total bilirubin \> 1.5 x ULN
• •AST/SGOT and ALT/SGPT \> 3.0 x ULN