Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

NCT ID: NCT00045188

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31

Brief Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the efficacy of STI571 in metastatic breast cancer (MBC) that demonstrates expression of CD117 (c-kit) and/ or PDGFR.

SECONDARY OBJECTIVES:

I. To determine the clinical activity of STI571 in MBC with expression of CD117 (ckit) and/ or PDGFR by evaluating progression-free survival (PFS).

II. To determine the toxicity profile and tolerability of STI571 in patients with MBC.

III. To define serum, tissue and imaging surrogate endpoints of activity of STI571 in MBC.

OUTLINE:

Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (imatinib mesylate)

Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Optional correlative studies

Interventions

imatinib mesylate

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Optional correlative studies

Intervention Type: OTHER

Other Intervention Names

CGP 57148; Gleevec; Glivec

Eligibility Criteria

Inclusion Criteria

• 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
• Female or male
• Not specified
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 12 weeks
• Absolute neutrophil count at least 1,500/mm^3
• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin normal
• AST or ALT no greater than 2.5 times upper limit of normal
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• 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
• No concurrent biologic agents
• 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
• Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed
• At least 4 weeks since prior radiotherapy and recovered
• Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed
• At least 2 weeks since prior minor surgery
• At least 4 weeks since prior major surgery
• Recovered from prior surgery
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Cristofanilli

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

IDO1-691

Identifier Type: -

Identifier Source: secondary_id

N01CM17003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000256915

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02491

Identifier Type: -

Identifier Source: org_study_id