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

NCT00323063 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-03-29

Study results available
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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.

Conditions

Interventions

DRUG

gemcitabine hydrochloride

Given IV

DRUG

imatinib mesylate

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Deborah R. Toppmeyer, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2011-04-15
Completion
2016-06-20

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323063 on ClinicalTrials.gov