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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

SWOG S1007 Phase III Randomized Study of Standard Adjuvant Endocrine Therapy With Versus Without Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive, and HER2-Negative Breast Cancer

Purpose

To determine the effect of endocrine therapy with versus without chemotherapy in patients with node-positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®.

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically confirmed invasive breast cancer meeting the following criteria:
    1. 1-3 node-positive disease (pN1mi, pN1a, pN1b, or pN1c) by sentinel node biopsy or axillary lymph node dissection
    2. Patients with positive sentinel node are not required to undergo full axillary lymph node dissection, at the discretion of the treating physician
    3. Positive estrogen receptor (ER) and/or progesterone receptor (PR) status according to American Society of Clinical Research/College of American Pathologists (ASCO/CAP) guidelines
    4. Considered positive if = 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal [normal epithelial elements] and external controls
    5. Negative HER-2 as determined by IHC or non-amplified fluorescence in situ hybridization (FISH) or chromogen in situ hybridization (CISH) for screening
    6. If HER2 is 2+ by IHC, FISH/CISH must be performed and must not be positive (must be a ratio of = 2.2)
    7. If IHC is 0 or 1+ by institutional standards, FISH/CISH is not required
    8. Patients with FISH/CISH in the indeterminate range (a ratio of 1.8 to 2.2) allowed provided they are not planning to receive treatment with trastuzumab
    9. Recurrence Score (RS) by Oncotype DX® = 25
    10. Submission of tissue (paraffin block from primary tumor, positive and negative lymph node block) from surgery required

Patient Exclusion Criteria:

  • None of the following allowed:
    1. No inflammatory breast cancer or metastatic disease
    2. Must have had breast-conserving surgery with planned radiotherapy or total mastectomy (with or without planned postmastectomy radiation) with clear margins (as per local institutional guidelines) within the past 56 days

    To Learn more
  • Phase

    3

    Gender

    Both Male and 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: 183095

    Date Last Changed: July 17, 2013


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