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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-47 Phase III Randomized Study of Adjuvant Chemotherapy With Versus Without Trastuzumab in Women With Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Purpose

To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met:
    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, pN2b, pN3a, or pN3b

  • If pN0, one of the following criteria must be met:
    1. pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative
    2. pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of = 25
    3. pT3 regardless of hormone-receptor status, histologic grade, and Oncotype DX® Recurrence Score

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 Note: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization]
    3. No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
    4. No previous ipsilateral invasive breast cancer or ipsilateral DCIS (patients with synchronous or previous ipsilateral LCIS are eligible)

    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: 183096

    Date Last Changed: July 17, 2013


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