Completed

Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer

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What is being tested

Capecitabine

+ Imatinib mesylate

Drug
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine. * Determine the 6-month progression-free survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate\* once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: \*If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.

Official TitlePhase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer 
NCT00087152
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

Criteria

* Histologically or cytologically confirmed adenocarcinoma of the breast * Stage IV measurable disease * Disease progression after at least 1, but no more than 2, prior chemotherapy regimens for metastatic disease * Patients with hormone-sensitive tumors must have received prior hormonal therapy * Patients with human epidermal growth factor receptor 2 (HER2)/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting (unless contraindicated) * No clinical evidence of or known brain or central nervous system (CNS) disease * Hormone Receptor status known * Female age 18 and over * Performance status Zubrod 0-2 * Absolute neutrophil count \> 1,500/mm\^3 * Leukocyte count \> 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin normal * aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 times upper limit of normal * Creatinine normal OR Creatinine clearance \> 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * No history of severe hypersensitivity reaction to compounds of similar chemical or biological composition to imatinib mesylate, capecitabine, or fluorouracil * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No prior biologic therapy (e.g., vaccines) * No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia * No prior capecitabine or fluorouracil for metastatic breast cancer * Prior hormonal therapy allowed * More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be the only site of disease * More than 4 weeks since prior major surgery * More than 4 weeks since prior therapy for breast cancer * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents or therapies for metastatic breast cancer

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers