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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Ductal Carcinoma In Situ (DCIS)
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

NSABP B-43 Phase III Randomized Study of Radiotherapy With Versus Without Trastuzumab (Herceptin®) in Women With HER2-Positive Ductal Carcinoma In Situ Who Underwent Lumpectomy

Purpose

To determine the value of radiotherapy with vs without trastuzumab (Herceptin®) in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • 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:
    1. Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed)
    2. No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins)

Patient Exclusion Criteria:

  • None of the following allowed:
    1. Patients who require mastectomy
    2. Invasive (including microinvasion staged as T1mic) breast cancer (DCIS "suspicious" for microinvasion, but not confirmed, allowed)
    3. Nodal staging of pN1 (including pN1mi) (axillary staging not required)
    4. DCIS present in more than one quadrant (multicentric)
    5. Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign
    6. Contralateral breast cancer (including DCIS)
    7. History of breast cancer, including DCIS (history of LCIS allowed)

    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: 183100

    Date Last Changed: July 17, 2013


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