Inclusion Criteria:

- Histologically documented breast cancer (either primary or metastatic site) that is
ER-negative, PR-negative, and HER2 non-over expressing by immunohistochemistry (0, 1)
or in situ hybridization (ISH) including; fluorescence (FISH) in situ hybridization /
chromogenic in situ hybridization (CISH) with a ratio < 2.0

- One to three prior chemotherapy regimens in the metastatic setting. Prior
adjuvant/neoadjuvant therapy is allowed. Prior Gemcitabine and/or Platinum agents are
allowed.

- Metastatic breast cancer (Stage IV)

- Female, ≥18 years of age

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

- Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1500/mm3,
platelets ≥100,000/dL, hemoglobin ≥9 g/dL, bilirubin ≤1.5 mg/dL, serum creatinine
≤1.5 mg/dL or creatinine clearance ≥60 mL/min, alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver
involvement or ≤5 times the upper limit of normal with liver involvement

- For women of child bearing potential, documented negative pregnancy test within two
weeks of EAP entry and agreement to acceptable birth control during the duration of
the EAP therapy

- Capability to understand and comply with the protocol and signed informed consent
document

Exclusion Criteria:

- Systemic anticancer therapy within 14 days of the first dose of study drug

- Has not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0, with the exception
of alopecia, related to anticancer therapy prior to the first dose of study drug

- Major medical conditions that might affect EAP participation (e.g. uncontrolled
pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)

- Brain metastases requiring steroids or expected to require other therapeutic
intervention during study participation, including WBRT and intrathecal therapy.
Patients must be > 21-days from neurosurgical intervention

- Pregnant or breastfeeding

- Inability or unwillingness to abide by the EAP protocol or cooperate fully with the
investigator or designee

Enrollment is limited and will be determined by a validated Random-Selection Process
administered by NORD (National Organization of Rare Disorders).