A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer

Inclusion Criteria:

- Histologically documented breast cancer (either primary or metastatic site) that is
ER-negative, PR-negative, and HER2 non-overexpressing by immunohistochemistry (0, 1) or
fluorescence in situ hybridization (FISH).

Triple-negative tumors were defined by the following criteria:

   - HER2-non-overexpressing: FISH-negative (defined by ratio <2.2) or, immunohistochemical
   (IHC) 0, IHC 1+ or, IHC 2+ or IHC 3+ and FISH-negative.

   - ER- and PR-negative: <10% tumor staining by immunohistochemistry (IHC).

      - Never having received chemotherapy for metastatic disease or, having received 1
      or 2 prior chemotherapy regimens in the metastatic setting (Prior
      adjuvant/neoadjuvant therapy was allowed);

      - Metastatic breast cancer (Stage IV) with measurable disease by RECIST 1.1
      criteria;

      - 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;

      - Radiation therapy completed at least 14 days before study dosing on day 1;
      radiated lesions may not have served as measurable disease;

      - Central nervous system metastases allowed if subject did not require steroids,
      whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were
      clinically stable without symptomatic progression;

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

      - Tissue block (primary or metastatic) or readily available fresh frozen tumor
      tissue for PARP expression and other pharmacogenomic studies recommended
      (although its absence will not exclude subjects from participating);

      - No other diagnosis of malignancy (with exception of non melanoma skin cancer or a
      malignancy diagnosed ≥5 years ago);

      - Obtained informed consent;

      - 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;

   - Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib

   - Had not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute
   Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0 or to within 10% of
   baseline values due to investigational drugs or other medications administered more
   than 30 days prior to study enrollment;

   - Major medical conditions that might have affected study participation (e.g.
   uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac
   disease);

   - Concurrent radiation therapy intended to treat primary tumor not permitted throughout
   the course of the study; palliative radiation was acceptable;

   - Leptomeningeal disease or brain metastases requiring steroids or other therapeutic
   intervention;

   - Pregnancy or breastfeeding;

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