Last updated on June 2019

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy


Brief description of study

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Detailed Study Description

Study Outline:

  • All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively.
  • Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study.
  • Patients whose sentinel lymph node status is cannot be/is not determined intraoperatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively.
  • Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively.
  • ALND is not to be performed prior to registration/randomization.
  • Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial.

The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens.

Primary Objective:

  • To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy

Secondary Objectives:

  • To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy
  • To obtain an estimate of the distribution of residual disease burden scores for each treatment arm
  • To estimate the distribution of overall survival for each treatment arm

Patients may receive adjuvant and ancillary therapy as appropriate per the protocol.

Adjuvant Therapy:

  • Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion.
  • Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period).
  • Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed.

Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation.

Ancillary Therapy:

  • Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate.

Patients are followed up for 5 years after completion of radiation therapy.

Clinical Study Identifier: NCT01901094

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Chattanooga, TN United States
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The West Clinic - Wolf River

Germantown, TN United States
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Methodist Hospital

Memphis, TN United States
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Nashville Breast Center

Nashville, TN United States
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Texas Oncology-Arlington South

Arlington, TX United States
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Texas Oncology Bedford

Bedford, TX United States
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Texas Oncology-Flower Mound

Flower Mound, TX United States
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Texas Oncology-Grapevine

Grapevine, TX United States
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M D Anderson Cancer Center

Houston, TX United States
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University Medical Center

Lubbock, TX United States
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Texas Oncology-McKinney

McKinney, TX United States
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Texas Cancer Center-Sherman

Sherman, TX United States
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Sandra L Maxwell Cancer Center

Cedar City, UT United States
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Logan Regional Hospital

Logan, UT United States
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Riverton Hospital

Riverton, UT United States
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LDS Hospital

Salt Lake City, UT United States
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South Jordan Health Center

South Jordan, UT United States
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Norris Cotton Cancer Center-North

Saint Johnsbury, VT United States
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Inova Alexandria Hospital

Alexandria, VA United States
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Sentara Martha Jefferson Hospital

Charlottesville, VA United States
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Inova Fair Oaks Hospital

Fairfax, VA United States
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Fredericksburg Oncology Inc

Fredericksburg, VA United States
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Harrison Medical Center

Bremerton, WA United States
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Tri-Cities Cancer Center

Kennewick, WA United States
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Jefferson Healthcare

Port Townsend, WA United States
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Compass Oncology Vancouver

Vancouver, WA United States
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United Hospital Center

Bridgeport, WV United States
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Saint Mary's Medical Center

Huntington, WV United States
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Aurora Health Center-Fond du Lac

Fond Du Lac, WI United States
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Aurora Cancer Care-Grafton

Grafton, WI United States
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Aurora BayCare Medical Center

Green Bay, WI United States
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UW Cancer Center Johnson Creek

Johnson Creek, WI United States
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Bay Area Medical Center

Marinette, WI United States
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Marshfield Medical Center

Marshfield, WI United States
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Aurora Cancer Care-Milwaukee

Milwaukee, WI United States
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Aurora Sinai Medical Center

Milwaukee, WI United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Aurora Cancer Care-Racine

Racine, WI United States
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Saint Michael's Hospital

Stevens Point, WI United States
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Aurora Cancer Care-Waukesha

Waukesha, WI United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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Kaiser Permanente-Fremont

Fremont, CA United States
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Kaiser Permanente-Fresno

Fresno, CA United States
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Kaiser Permanente-Modesto

Modesto, CA United States
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Kaiser San Rafael-Gallinas

San Rafael, CA United States
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UCHealth Memorial Hospital Central

Colorado Springs, CO United States
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Sentara Princess Anne Hospital

Virginia Beach, VA United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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Mount Sinai Union Square

New York, NY United States
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Mount Sinai West

New York, NY United States
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Mary Bird Perkins Cancer Center

Baton Rouge, LA United States