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

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm II (Gemcitabine Hydrochloride + Imatinib)	gemcitabine hydrochloride	Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
Arm I (Gemcitabine Hydrochloride)	gemcitabine hydrochloride	Patients receive gemcitabine hydrochloride IV on days 3 and 10.
Arm II (Gemcitabine Hydrochloride + Imatinib)	imatinib mesylate	Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.

Primary Outcome Measures

Name	Time	Method
Time to Progression	5 years	Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).

Secondary Outcome Measures

Name	Time	Method
Response Rate (Complete and Partial Response)	5 years	Overall response rate was evaluated every 2 cycles (six weeks) for both groups using international criteria by the Response Evaluation Criteria in Solid Tumors (RECISTv1.0) for target lesions and were assessed by CT or MRI. Response rates were defined as complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response(OR) defined as OR=CR + PR
Overall Survival	5 years

Locations (9): Saint Peter's University Hospital
🇺🇸
New Brunswick, New Jersey, United States
Cooper Hospital/University Medical Center
🇺🇸
Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey at Hamilton
🇺🇸
Hamilton, New Jersey, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center
🇺🇸
Baltimore, Maryland, United States
Rutgers Cancer Institute of New Jersey
🇺🇸
New Brunswick, New Jersey, United States
Mountainside Hospital
🇺🇸
Montclair, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
NJ Medical School
🇺🇸
Newark, New Jersey, United States