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Active Clinical Trials: Breast- Adjuvant HER2 Neu Pos

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ProtocolTitle
NSABP-B-43A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy. (1675)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    Histologically confirmed ductal carcinoma in situ (DCIS)

    Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
    HER2 receptor-positive as determined by central testing
    Must have undergone resection by lumpectomy and meets the following criteria:

    Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed)
    No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins)
    None of the following allowed:

    Patients who require mastectomy
    Invasive (including microinvasion staged as T1mic) breast cancer (DCIS "suspicious" for microinvasion, but not confirmed, allowed)
    Nodal staging of pN1 (including pN1mi) (axillary staging not required)
    DCIS present in more than one quadrant (multicentric)
    Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign
    Contralateral breast cancer (including DCIS)
    History of breast cancer, including DCIS (history of LCIS allowed)
    Hormone receptor status:

    Estrogen receptor and/or progesterone receptor-positive or -negative
    Must submit tumor block for correlative studies
    PATIENT CHARACTERISTICS:

    Pre- or postmenopausal
    ECOG performance status 0-1
    Life expectancy e 10 years (excluding diagnosis of DCIS)
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective non-hormonal contraception during and for 6 months after completion of treatment with trastuzumab (Herceptin®)
    No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
    No cardiac disease that would preclude the use of study treatment drugs, including, but not limited to, any of the following:

    Active cardiac disease

    Angina pectoris that requires the use of anti-anginal medication
    Ventricular arrhythmias except for benign premature ventricular contractions controlled by medication
    Conduction abnormality requiring a pacemaker
    Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
    Clinically significant valvular disease
    History of cardiac disease

    Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function
    Documented congestive heart failure
    Documented cardiomyopathy
    No uncontrolled hypertension (i.e., systolic BP > 180 mm Hg and/or diastolic BP > 100 mm Hg) (hypertension that is well controlled on medication allowed)
    No other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiotherapy or would prevent prolonged follow-up
    No other malignancies unless patient has been disease-free e 5 years and at low risk for recurrence, except for treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell or squamous cell carcinoma of the skin
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    No prior whole or partial breast irradiation
    No prior anthracycline chemotherapy for any malignancy
    No investigational agents within the past 30 days
    No other cancer therapy until the time of first cancer recurrence or second primary cancer

  • Consent Forms: B-43 Pre-Entry Consent, B-43 Main Consent
NSABP-B-44-IA Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab (1563)
  • Eligibility: click to view information

    **Open to Limited Institutions Only**

    **The MCRC does not participate in the optional serum & plasma portion of this study, only tissue submission for HER2/neu status**

    Patient selection guidelines
    *Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
    *Women who have had breast reconstruction utilizing tissue expanders must be in
    agreement with not having expansion performed within 2 weeks before the first dose of bevacizumab, during bevacizumab therapy, and until 6 weeks following the last dose of bevacizumab
    *Women of reproductive potential must agree to use an effective non-hormonal
    method of contraception
    *Submission of tumor samples from the breast surgery for central HER2 testing is
    required for all patients prior to enrollment in the BETH Trial (see Sections

    Conditions for patient eligibility
    *Patients must be female.
    *The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
    *The breast cancer must be HER2-positive based on test results as follows:
    - Local testing (See Protocol)& Central testing
    *By pathologic evaluation, primary tumor must be pT1-3
    *By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a,pN1b, pN1c), pN2a, pN3a, or pN3b
    *If pN0, at least one of the following criteria must be met:
    Pathologic tumor size > 2.0 cm, ER negative and PgR negative,Histologic and/or nuclear grade 2 (intermediate) or 3 (high, or Age < 35 years
    *Patients must have undergone either a total mastectomy or breast conserving
    surgery (lumpectomy).
    * For patients who undergo lumpectomy, the margins of the resected specimen
    must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS)as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after reexcision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
    *For patients who undergo mastectomy, margins must be free of gross residual
    tumor. Patients with microscopic positive margins are eligible (see Section 8.8
    for radiation therapy [RT] requirements).
    *Patients must have completed one of the following procedures for evaluation of
    pathologic nodal status:
    Sentinel lymphadenectomy followed by removal of additional non-sentinel, lymph nodes if the sentinel node (SN) is positive, Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b, or Axillary lymphadenectomy without SN isolation procedure.
    * The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
    *Patients must have ER analysis performed on the primary tumor prior to
    randomization. If ER analysis is negative, then PgR analysis must also be performed.
    *LVEF assessment must be performed within 3 months prior to randomization. It
    is preferred that LVEF assessment be performed by 2-D echocardiogram;
    however, MUGA scan may be substituted based on institutional preferences.
    The LVEF must be = 55% regardless of the cardiac imaging facility’s lower
    limit of normal (LLN). (The same method should be used throughout the
    study; all assessments should be performed at the same cardiac imaging facility
    used at baseline.)
    *The ECG (performed within 3 months prior to randomization) must not have
    demonstrated any of the following conditions:
    • ventricular arrhythmias except for benign premature ventricular contractions;
    • supraventricular and nodal arrhythmias requiring a pacemaker or not
    controlled with medication; and
    • conduction abnormality requiring a pacemaker.

    Conditions for patient ineligibility

    *Inflammatory breast cancer.
    *Definitive clinical or radiologic evidence of metastatic disease.
    *Synchronous contra

  • Consent Forms: B-44-I BETH Consent, B-44-I BETH Her2Testing Consent
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