Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria are met:

• Female subjects, age ≥ 18 years at the time informed consent is signed
• Pathologically confirmed adenocarcinoma of the breast
• Pathologically confirmed as triple negative, source documented, defined as both of the following
• Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: 60 mL/min (by Cockcroft-Gault)
• Females of child-bearing potential [defined as a sexually mature women who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:
• Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and
• Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines
• Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
• Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

• Male subjects
• Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy & monoclonal antibody therapy are acceptable.
• Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease
• History of, or known current evidence of brain metastasis, including leptomeningeal involvement.
• Subjects with bone as the only site of metastatic disease
• Subjects with regional lymph node as the only site of metastatic disease
• Serious intercurrent medical or psychiatric illness, including serious active infection
• History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
• History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
• Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications
• Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
• Subjects who have received an investigational product within the previous 4 weeks prior to randomization
• Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are pe