SCCA Breast Cancer Clinical Trials
|Closed||Metastatic Breast Cancer||Expanded Access||
Purpose: The following trial is designed to offer pre-approval drug access to iniparib (a PARP inhibitor) in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3, multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol 20090301).
What is Expanded Access? Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. Read more about expanded access.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Female|
- Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-over expressing
- Zero to three prior chemotherapy regimens in the metastatic setting
- 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
- 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).
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.