Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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).
Clareo Health | An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
