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Male Breast CancerPhase 2NCT00045188

Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
imatinib mesylate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Aug 2002to Jul 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 51Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of STI571 in Metastatic Breast Cancer

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

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

Being tested
imatinib mesylate, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given PO

  • laboratory biomarker analysisOther

    Optional correlative studies

Study groups in NCT00045188
Study groupRoleWhat they receive
Treatment (imatinib mesylate)ExperimentalPatients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Incidence of adverse events

    Measured: Up to 2 years

  2. Time to progression

    Reported using the Kaplan-Meier method with 95% confidence intervals indicated.

    Measured: Up to 2 years

  3. Overall survival

    Reported using the Kaplan-Meier method with 95% confidence intervals indicated.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045188
Sponsor's protocol ID
NCI-2012-02491
Other IDs
IDO1-691, N01CM17003, CDR0000256915
Status last verified
Jan 2013
First submitted
6 Sep 2002
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 51 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response (CR + PR), as determined by the RECIST criteria (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.

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