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Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

Primary Purpose

Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (imatinib mesylate)

Arm Description

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

Outcomes

Primary Outcome Measures

Objective tumor response (CR + PR), as determined by the RECIST criteria

Secondary Outcome Measures

Incidence of adverse events
Time to progression
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Overall survival
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.

Full Information

First Posted
September 6, 2002
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045188
Brief Title
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Official Title
Phase II Trial of STI571 in Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (imatinib mesylate)
Arm Type
Experimental
Arm Description
Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
CGP 57148, Gleevec, Glivec
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Optional correlative studies
Primary Outcome Measure Information:
Title
Objective tumor response (CR + PR), as determined by the RECIST criteria
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Up to 2 years
Title
Time to progression
Description
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time Frame
Up to 2 years
Title
Overall survival
Description
Reported using the Kaplan-Meier method with 95% confidence intervals indicated.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Cristofanilli
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

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