Sponsor study identifier
Secondary identifiers
interventional
27
0 countries
N/A
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 8, 2004
Actual (reported)July 12, 2004
Actual (reported)December 2008
Actual (reported)December 2008
Actual (reported)June 9, 2014
Actual (reported)Confirmed Response Rate (Complete and Partial)
Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.
12 weeks
Progression-free Survival at 6 Months
Six months
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Every 3 weeks while on treatment for up to 3 years.
1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle
Chew HK, Barlow WE, Albain K, Lew D, Gown A, Hayes DF, Gralow J, Hortobagyi GN, Livingston R. A phase II study of imatinib mesylate and capecitabine in metastatic breast cancer: Southwest Oncology Group Study 0338. Clin Breast Cancer. 2008 Dec;8(6):511-5. doi: 10.3816/CBC.2008.n.062.
Chew HK, Barlow W, Albain K, et al.: SWOG 0338: a phase II trial of imatinib mesylate in combination with capecitabine in metastatic breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-10529, 2006.
Two-stage design, but did not have enough confirmed responses after the first stage to launch the second stage.
Helen K. Chew, MD
University of California, Davis
Kathy S. Albain, MD
Loyola University
27 participants (actual enrollment reported by the registry).
First Submitted
July 8, 2004
First Posted
July 12, 2004
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
June 9, 2014
Results First Posted
June 9, 2014
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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