Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

July 31, 2013

Study Completion Date

October 31, 2014

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Amrubicin

"Phase I: dose-escalating portion with the starting dose of amrubicin at 90mg/m\^2 IV q21 days. Dose escalations are as follows:~DL2 - 100mg/m\^2; DL3 - 110mg/m\^2; and DL4 - 120mg/m\^2. All cycles are q21 days~Phase II: Amrubicin will be administered at the maximum tolerated dose established in Phase I by IV every 21 days"

Trial Locations (16)

19611

Berks Hematology Oncology Associates, West Reading

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Consortium, Bethesda

23601

Peninsula Cancer Institute, Newport News

30501

Northeast Georgia Medical Center, Gainesville

33901

Florida Cancer Specialists, Fort Myers

37203

Tennessee Oncology, PLLC, Nashville

40207

Baptist Hospital East, Louisville

Norton Cancer Institute, Louisville

45242

Oncology Hematology Care, Inc, Cincinnati

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

68114

Nebraska Methodist Cancer Center, Omaha

70809

Hematology Oncology Clinic, LLP, Baton Rouge

72401

NEA Baptist Clinic, Jonesboro

76104

The Center for Cancer and Blood Disorders, Fort Worth

03801

Portsmouth Regional Hospital, Portsmouth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER