Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.
Timeline
- Start
- 2006-05-01
- Primary completion
- 2011-04-15
- Completion
- 2016-06-20
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow accrual”
registry analysis (other test); Arm I (Gemcitabine Hydrochloride) vs Arm II (Gemcitabine Hydrochloride + Imatinib); p = 0.3; Log Rank NCT00323063 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Imatinib | Small molecule | — | Oral |