Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
- Compare time to progression in patients with previously treated locally advanced or
metastatic breast cancer treated with gemcitabine hydrochloride with vs without
- Compare the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV on days 3 and 10.
- Arm II: Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral
imatinib mesylate once daily on days 1-5 and 8-12.
In both arms, treatment repeats every 21 days in the absence of disease progression or
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Antoinette R. Tan, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cooper Hospital/University Medical Center||Camden, New Jersey 08103|
|UMDNJ University Hospital||Newark, New Jersey 07103|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Saint Peter's University Hospital||New Brunswick, New Jersey 08901-1780|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Jersey Shore Cancer Center at Jersey Shore University Medical Center||Neptune, New Jersey 07754-0397|
|Mountainside Hospital||Montclair, New Jersey 07042|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|