193
Participants
Start Date
April 3, 2014
Primary Completion Date
February 21, 2021
Study Completion Date
September 9, 2022
Genomically Directed Monotherapy
Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:
Observation/Standard Therapy
Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Pinnacle Health Cancer Center, Harrisburg
Georgetown University: Lombardi Comprehensive Cancer Center, Washington D.C.
Meritus Center for Clinical Research, Hagerstown
Virginia Oncology Associates, Norfolk
Emory University: Winship Cancer Institute, Atlanta
University of Florida: Shands Cancer Center, Gainesville
Memorial Cancer Institute, Hollywood
Memorial Breast Cancer Center: Memorial West, Pembroke Pines
University of Miami, Sylvester Comprehensive Cancer Center, Miami
University of Alabama Hematology Oncology Clinic at Medical West, Birmingham
Erlanger Health System, Chattanooga
University of Cincinnati Cancer Institute, Cincinnati
Community Hospital of Anderson and Madison County, Inc, Anderson
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Community Regional Cancer Center, Indianapolis
St. Vincent Hospital, Indianapolis
Community Healthcare System: Monroe Medical Associates, Munster
IU Health Goshen Hospital, Goshen
Northern Indiana Cancer Research Consortium, South Bend
Fort Wayne Oncology & Hematology, Inc., Fort Wayne
IU Health Arnett Cancer Center, Lafayette
Froedtert/Medical College of Wisconsin, Milwaukee
Aurora Health Care, Wauwatosa
University of Chicago Medicine, Chicago
Washington University: Siteman Cancer Center, St Louis
Nebraska Cancer Specialists, Omaha
Mercy Clinic Oncology & Hematology: McAuley, Oklahoma City
Joe Arrington Cancer Research and Treatment Center, Lubbock
Tufts Medical Center, Boston
Collaborators (1)
Hoosier Cancer Research Network
OTHER
Vera Bradley Foundation for Breast Cancer
OTHER
Walther Cancer Institute
OTHER
Indiana University
OTHER
Bryan Schneider, MD
OTHER