An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer

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).