To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients

Inclusion Criteria:

• Adult women (≥ 18 years of age) with advanced TNBC.
• Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
• ER/PgR negativity to follow local guidelines
• If IHC HER2 2+, a negative FISH test is required
• A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
• Patients must have:

At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)

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

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com