Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045188
  Purpose

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
Breast Cancer
Drug: imatinib mesylate
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of STI571 in Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2002
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of imatinib mesylate in patients with metastatic breast cancer.
  • Determine the clinical activity of this drug, in terms of progression-free survival, in these patients.
  • Determine the toxicity profile and tolerability of this drug in these patients.
  • Determine serum, tissue, and imaging surrogate endpoints of activity of this drug in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic breast cancer
  • Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor

    • Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation
  • Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Bone disease may not be only source of measurable disease
    • Pleural or peritoneal ascites are not considered measurable disease
  • No known brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female or male

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST or ALT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No prior allergic reaction attributed to compounds of similar chemical or biologic composition to imatinib mesylate
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 1 week after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Chemotherapy
  • No concurrent biologic agents

Chemotherapy

  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens for metastatic disease

    • Therapy with high-dose regimens or bone marrow transplantation considered 1 regimen
  • At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed

Surgery

  • At least 2 weeks since prior minor surgery
  • At least 4 weeks since prior major surgery
  • Recovered from prior surgery

Other

  • Low-molecular weight heparin or heparin allowed for anticoagulation
  • No concurrent warfarin
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent investigational therapies or agents
  • No other concurrent anticancer therapy
  • No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit sections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045188

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Massimo Cristofanilli, MD M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Cristofanilli M, Morandi P, Krishnamurthy S, Reuben JM, Lee BN, Francis D, Booser DJ, Green MC, Arun BK, Pusztai L, Lopez A, Islam R, Valero V, Hortobagyi GN. Imatinib mesylate (Gleevec) in advanced breast cancer-expressing C-Kit or PDGFR-beta: clinical activity and biological correlations. Ann Oncol. 2008 Oct;19(10):1713-9. Epub 2008 May 29.
Chedid S, Booser D, Krishnamurthy S, et al.: Phase II study of imatinib mesylate (STI-571) for patients with metastatic breast cancer (MBC) with tumors that overexpress PDGFRβ and/or c-kit. [Abstract] Proceedings of the American Association for Cancer Research 45: A-2219, 178, 2004.

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

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
stage IV breast cancer

Study placed in the following topic categories:
Imatinib
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009