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Breast CancerPhase 2NCT00087152

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

A Phase 2 study testing Capecitabine and Imatinib mesylate in people with Breast Cancer, run by National Cancer Institute (NCI).

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

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Capecitabine and Imatinib mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
Jun 2004to Dec 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  • 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

About this study

Official title: Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer

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.

Read the detailed description

OBJECTIVES:

  • Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
  • Determine the 6-month progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate* once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: *If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.

Conditions
Breast Cancer
Being tested
Capecitabine, Imatinib mesylate
Keywords
stage IV breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

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

  • Imatinib mesylateDrug

    Also called Gleevec

    400 mg by mouth daily

Study groups in NCT00087152
Study groupRoleWhat they receive
Imatinib Mesylate & CapecitabineExperimentalNot described
Receives: Drug: Capecitabine; Drug: Imatinib mesylate

What is being measured

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

  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.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Progression-free Survival at 6 Months

    Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.

    Measured: Six months

  2. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Every 3 weeks while on treatment for up to 3 years.

Timeline

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

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 2008
  4. Study completionDec 2008

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087152
Sponsor's protocol ID
NCI-2012-03033
Other IDs
U10CA032102, S0338, CDR0000372950
Status last verified
Feb 2013
First submitted
8 Jul 2004
Last updated
9 Jun 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 19073506

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Imatinib mesylate in people with Breast Cancer, run by National Cancer Institute (NCI).

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

Who may be eligible to take part?

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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Confirmed Response Rate (Complete and Partial) (time frame: 12 weeks). 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 NCT00087152, which also lists 2 linked publications.

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 9 Jun 2014.

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