Ensayos clínicos

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
• Females of child bearing potential
  • Documented negative pregnancy test within two weeks of EAP entry
  • Agreement to acceptable birth control during the duration of the EAP therapy
• Capability to understand and comply with the protocol
• 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
  • 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)