Spots Global Cancer Trial Database for A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
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Trial Identification
Brief Title: A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
Official Title: A Phase II Study of NK012 in Locally Advanced Non-Resectable and Metastatic Breast Cancer Patients With Triple Negative Phenotype
Study ID: NCT00951054
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.
Detailed Description: This is a Phase II, open label, single arm, multicenter study of NK012 in patients with locally advanced non-resectable and metastatic breast cancer with ER-negative, PR negative and HER2-negative phenotype. NK012 will be administered by infusion over 30 minutes once every 28 days (on Day 1 of each cycle). Patients will be screened for UGT1A1 polymorphism prior to enrollment in order to determine their starting dose.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Contact Details
Name: Denise A Yardley, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
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