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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045188 |
RATIONALE: Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of STI571 in Metastatic Breast Cancer |
Study Start Date: | August 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor
At least 1 unidimensionally measurable lesion
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy regimens for metastatic disease
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Massimo Cristofanilli, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000256915, MDA-ID-01691, NCI-5580 |
Study First Received: | September 6, 2002 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00045188 |
Health Authority: | United States: Federal Government |
male breast cancer recurrent breast cancer stage IV breast cancer |
Imatinib Skin Diseases Breast Neoplasms, Male |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |