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Active Clinical Trials: Breast- Metastatic Chemotherapy 2nd or 3rd Line or greater

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ProtocolTitle
NCCTG-N0733Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive, Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane (1663)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Histologically confirmed breast cancer, meeting one of the following criteria:

    Locally advanced disease (i.e., stage IIIB or IIIC [T4 primary tumor] disease)
    Metastatic disease
    Disease progressed after treatment with regimens that included trastuzumab (Herceptin®) in combination with an anthracycline and/or a taxane

    Must have received 1-2 prior chemotherapy regimens in the neoadjuvant, adjuvant, or metastatic setting

    One regimen must have included treatment with an anthracycline and/or a taxane
    Prior treatment with trastuzumab required unless there is a contraindication for trastuzumab treatment
    HER2-positive disease, defined by any of the following:

    Validated IHC assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells)
    Average HER2 gene copy number > 6
    Gene amplified (HER2:D17Z1 ratio > 2.20)
    Measurable disease according to RECIST criteria
    No evidence of active brain metastases, including leptomeningeal involvement

    CNS metastasis controlled* by prior surgery and/or radiotherapy is allowed NOTE: *To be considered controlled, there must have been no symptoms for at least 2 months or no evidence of progression prior to study entry AND corticosteroid therapy must have been discontinued
    Hormone receptor status not specified
    PATIENT CHARACTERISTICS:

    Menopausal status not specified
    ECOG performance status 0-2
    Life expectancy > 3 months
    WBC = 3,000/mm³
    ANC = 1,500/mm³
    Platelet count = 75,000/mm³
    Hemoglobin > 9.0 g/dL
    Total bilirubin = 1.5 times upper limit of normal (ULN)
    AST and ALT = 2.5 times ULN (5 times ULN if elevations are due to liver metastases)
    Serum creatinine = 1.5 times ULN
    Creatinine clearance = 30 mL/min
    Fasting glucose < 120 mg/dL

    Diabetes allowed provided blood glucose level meets the above criterion
    INR = 1.5 times ULN
    LVEF = 50% by MUGA or ECHO
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception
    Willing to provide tissue and blood samples for research purposes
    Able to complete questionnaires by self or with assistance
    No other stage III or IV invasive cancer within the past 5 years
    No other malignancy requiring active treatment, except nonmelanoma skin cancer or carcinoma in situ of the cervix

    History of prior malignancy allowed provided patient is not receiving other specific treatment for their malignancy
    No current, active hepatic or biliary disease, except Gilbert syndrome's or asymptomatic gallstones
    No New York Heart Association class III or IV cardiovascular disease
    No concurrent uncontrolled illness including, but not limited to, any of the following:

    Poorly controlled diabetes
    Ongoing or active infection
    Symptomatic congestive heart failure
    Unstable angina pectoris
    Cardiac arrhythmia
    Psychiatric illness/social situation that would preclude compliance with study requirements
    No co-morbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety of the prescribed study regimens
    Not immunocompromised (other than that related to the use of corticosteroids), including known HIV-positivity with an AIDS-defining illness

    HIV-positive patients with a CD4 count within normal range and who have no history of an AIDS-defining illness are eligible
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
    More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
    More than 4 weeks since prior radiotherapy, except a single dose of palliative radiotherapy or radiotherapy to a non-target lesion

    Prior radiotherapy to a target lesion is allowed only if there has been clear progression of the lesion since completion of radiotherapy
    Recovered from prior radiotherapy
    No more than 2 prior chemotherapy regimens for metastatic d

  • Consent Forms: N0733 Consent
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