Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0338 S0338, NCT00087152

Objectives

1. Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
2. Determine the 6-month progression-free survival of patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.
4. 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.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the breast
  • Stage IV disease



• 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 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 CNS disease



• Hormone receptor status:
  • Receptor status known

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior biologic therapy (e.g., vaccines)
• No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia

Chemotherapy

• See Disease Characteristics
• No prior capecitabine or fluorouracil for metastatic breast cancer

Endocrine therapy

• See Disease Characteristics
• Prior hormonal therapy allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy
  • Previously irradiated area(s) must not be the only site of disease

Surgery

• More than 4 weeks since prior major surgery

Other

• 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

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Leukocyte count > 3,000/mm³
• Platelet count > 100,000/mm³

Hepatic

• Bilirubin normal
• AST and ALT < 2.5 times upper limit of normal

Renal

• Creatinine normal

  OR

• Creatinine clearance > 60 mL/min

Other

• 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

Expected Enrollment

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.

Outcomes

Confirmed response rate (complete and partial)
Progression-free survival at 6 months
Toxicity
Correlation of c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression

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.

Chew HK, Barlow WE, Albain K, et al.: A Phase II Study of Imatinib Mesylate and Capecitabine in Metastatic Breast Cancer: Southwest Oncology Group Study 0338. Clin Breast Cancer 8 (6): 511-5, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Helen Chew, MD, Study coordinator		Ph: 916-734-3771
Kathy Albain, MD, Study coordinator		Ph: 708-327-3304 Email: kalbain@lumc.edu

Registry Information
Official Title		Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer
Trial Start Date		2004-06-15
Registered in ClinicalTrials.gov		NCT00087152
Date Submitted to PDQ		2004-05-21
Information Last Verified		2005-09-28
NCI Grant/Contract Number		U10-CA32102

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