Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT01130259
Eligibility Criteria:
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).
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01130259
Study Brief:
Protocol Section:
NCT01130259