S0338, Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer

NCT00087152 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-03033U10CA032102S0338CDR0000372950
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

Study Arms (1)

Imatinib Mesylate & Capecitabine

EXPERIMENTAL

Drug: Capecitabine; Drug: Imatinib mesylate

Interventions

Capecitabine DRUG

1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle

Also known as: Xeloda

Imatinib Mesylate & Capecitabine

Imatinib mesylate DRUG

400 mg by mouth daily

Also known as: Gleevec

Imatinib Mesylate & Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Related Publications (2)

• 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.

  PMID: 19073506 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Limitations and Caveats

Two-stage design, but did not have enough confirmed responses after the first stage to launch the second stage.

Results Point of Contact

• Title: Lead Statistician - Breast Cancer Committee
• Organization: SWOG

williamb@crab.org

(206) 839-1761

Study Officials

• Helen K. Chew, MD

  University of California, Davis

  STUDY CHAIR

• Kathy S. Albain, MD

  Loyola University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2013-02