Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
OBJECTIVES:
Primary
- Compare time to progression in patients with previously treated locally advanced or
metastatic breast cancer treated with gemcitabine hydrochloride with vs without
imatinib mesylate.
Secondary
- 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
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
5 years
No
Antoinette R. Tan, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Institutional Review Board
040504
NCT00323063
May 2006
December 2013
Name | Location |
---|---|
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 |