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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

NSABP B-49 Phase III Study of Docetaxel and Cyclophosphamide Versus Anthracycline-Based Chemotherapy Regimens in Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Purpose

To determine if the docetaxel and cyclophosphamide (TC) regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (DFS) by combining B-49 data with the docetaxel, doxorubicin, and cyclophophamide (TAC) and TC arms

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • The breast cancer must be HER2-negative based on current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Human Epidermal
  • Growth Factor Receptor 2 Testing in Breast Cancer
  • If the result of the in situ hybridization testing (fluorescence in situ hybridization [FISH], chromagen in situ hybridization [CISH], or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy
  • All of the following staging criteria must be met according to AJCC criteria:
    1. By pathologic evaluation, primary tumor must be pT1-3
    2. 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:
    1. Estrogen receptor (ER) negative AND progesterone receptor (PgR) negative
    2. Pathologic tumor size > 2.0 cm
    3. T1c (pathologic tumor size > 1.0 cm but ≤ 2.0 cm) and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of ≥ 25

Patient Exclusion Criteria:

  • None of the following allowed:
    1. No T4 tumors, including inflammatory breast cancer
    2. No definitive clinical or radiologic evidence of metastatic disease
    3. No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral ductal carcinoma in situ [DCIS] are eligible)
    4. No history of ipsilateral invasive breast cancer or ipsilateral DCIS
    5. Patients must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)

    To Learn more
  • Phase

    3

    Gender

    Female

    Age

    18 and up

    Overall Status

    Recruiting

    Facility Type

    N/A

    Contact

    Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
    Sherman Health
    1425 North Randall Road
    Elgin, IL 60123
    Phone: 224-783-2907
    Fax: 224-783-3071

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    If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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    CW ID: 183098

    Date Last Changed: July 17, 2013


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