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 ofthe following criteria are met:

1. Female subjects, age ≥ 18 years at the time informed consent is signed

2. Pathologically confirmed adenocarcinoma of the breast

3. Pathologically confirmed as triple negative, source documented, defined as both of thefollowing

4. Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumorcell nuclei are immunoreactive in the presence of evidence that the sample canexpress ER or PgR (positive intrinsic controls)

5. Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Societyof Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i.Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH)negative (or equivalent negative test). Subjects with IHC 2 must have a negativeby Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).

6. Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2positive) must have pathologic confirmation of triple negative disease in at least oneof the current sites of metastasis

7. Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy;unless (a) anthracycline treatment was not indicated or was not the best treatmentoption for the subject in the opinion of the treating physician; and (b) anthracyclinetreatment remains not indicated or, in the opinion of the treating physician, is notthe best treatment option for the subject's metastatic disease. a. Newly diagnosed subjects presenting with TNMBC are eligible for the study ifanthracycline treatment is not indicated or is not the best treatment option for thesubject in the opinion of the treating physician.

8. Subjects with measurable metastatic disease, defined by Response Evaluation Criteriain Solid Tumors 1.1 (RECIST 1.1) guidelines

9. Life expectancy ≥ 16 weeks from randomization

10. No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapyand/or monoclonal antibody therapy are acceptable. Prior treatments must have beendiscontinued at least 30 days prior to start of study treatment and all relatedtoxicities must have resolved to Grade 1 or less.

11. Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed atleast 6 months before randomization with all related toxicities resolved, anddocumented evidence of disease progression per RECIST 1.1 guidelines is required. a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, orplatinum agents, the treatment must have completed at least 12 months beforerandomization

12. Prior radiotherapy must have completed before randomization, with full recovery fromacute radiation side effects. At least one measurable lesion must be completelyoutside the radiation portal or there must be unequivocal radiologic or clinical examproof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines

13. At least 30 days from major surgery before randomization, with full recovery

14. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

15. Subject has the following blood counts at screening:

• Absolute Neutrophil Count (ANC) ≥ 1500/mm^2 ;

• Platelets ≥ 100,000/mm^2 ;

• Hemoglobin (Hgb) ≥ 9 g/dL

14. Subject has the following blood chemistry levels at screening:

• Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT),Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); if hepatic metastases present ≤ 5.0 x ULN

• Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubinwithin normal range in subjects with documented Gilbert's Syndrome

• Creatinine clearance > 60 mL/min (by Cockcroft-Gault)

15. Females of child-bearing potential [defined as a sexually mature women who (1) havenot undergone hysterectomy (the surgical removal of the uterus) or bilateraloophorectomy (the surgical removal of both ovaries) or (2) have not been naturallypostmenopausal for at least 24 consecutive months (i.e., has had menses at any timeduring the preceding 24 consecutive months)] must:

• Demonstrate a negative serum pregnancy test result at screening (performed bycentral lab) confirmed by local negative urine pregnancy dipstick within 72 hoursprior to the first dose of IP); pregnancy test with sensitivity of at least 25mIU/mL; and

• Either commit to true abstinence* from heterosexual contact (which must bereviewed on a monthly basis) or agree to use, and be able to comply with, twophysician approved effective contraception methods (oral, injectable, orimplantable hormonal contraceptive; tubal ligation; intra-uterine device; barriercontraceptive 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 afterdiscontinuation of the study or longer as required by local guidelines

16. Females must abstain from breastfeeding starting at randomization, during studyparticipation and for 28 days or longer as required by local guidelines, after IPdiscontinuation

17. Understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures are conducted

18. 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 criteriaapply:

1. Male subjects

2. Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Priorimmunotherapy & monoclonal antibody therapy are acceptable.

3. Subjects who received prior cytotoxic chemotherapy after incomplete resection oflocoregional recurrent disease

4. History of, or known current evidence of brain metastasis, including leptomeningealinvolvement.

5. Subjects with bone as the only site of metastatic disease

6. Subjects with regional lymph node as the only site of metastatic disease

7. Serious intercurrent medical or psychiatric illness, including serious activeinfection

8. History of class II-IV congestive heart failure or myocardial infarction within 6months of randomization

9. History of other primary malignancy in the last 5 years prior to randomization.Subjects with prior breast cancer history are eligible, however, the most recentlyobtained biopsy must demonstrate triple negative disease (source documented). Subjectswith prior history of in situ cancer or basal or localized squamous cell skin cancerare eligible.

10. Subjects with a history of interstitial lung disease, history of slowly progressivedyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergieswhich, in the opinion of the investigator, may lead to serious complications

11. Peripheral neuropathy Grade ≥ 2 by National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI CTCAE) v4.0

12. Subjects who have received an investigational product within the previous 4 weeksprior to randomization

13. Subject is currently enrolled, or will enroll in a different clinical study in whichinvestigational therapeutic procedures are performed or investigational therapies areadministered while participating in this study

14. Pregnant or nursing women

15. Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin orany other platin, or nucleoside analogue agents

16. Any significant medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from participating in the study

17. Any condition including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if she were to participate in the study

18. Any condition that confounds the ability to interpret data from the study

19. History of seropositive human immunodeficiency virus (HIV)

20. Subjects who are receiving immunosuppressive or myelosuppressive medications thatwould, in the opinion of the investigator, increase the risk of serious neutropeniccomplications