NCT00323063

Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer

Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Given IV
DRUG	imatinib mesylate	Given orally

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-04-15
• Completion: 2016-06-20
• First posted: 2006-05-09
• Last updated: 2023-03-29
• Results posted: 2017-11-29

Locations

9 sites across 1 country: United States