Last updated on August 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

Find a site near you

Start Over

Middlesex Hospital

Middletown, CT United States
  Connect »

Henry Ford Wyandotte Hospital

Wyandotte, MI United States
  Connect »

Geauga Hospital

Chardon, OH United States
  Connect »

SIH Cancer Institute

Carterville, IL United States
  Connect »

Jefferson Hospital

Jefferson Hills, PA United States
  Connect »

Katmai Oncology Group

Anchorage, AK United States
  Connect »

University Pointe

West Chester, OH United States
  Connect »

Sharp Memorial Hospital

San Diego, CA United States
  Connect »

Farmington Health Center

Farmington, UT United States
  Connect »

Norwalk Hospital

Norwalk, CT United States
  Connect »

Piedmont Hospital

Atlanta, GA United States
  Connect »

Ingalls Memorial Hospital

Harvey, IL United States
  Connect »

Mercy Health Saint Mary's

Grand Rapids, MI United States
  Connect »

Sentara Leigh Hospital

Norfolk, VA United States
  Connect »

Saint Francis Cancer Center

Greenville, SC United States
  Connect »

Physicians' Clinic of Iowa PC

Cedar Rapids, IA United States
  Connect »

Mercy Hospital Joplin

Joplin, MO United States
  Connect »

Baystate Medical Center

Springfield, MA United States
  Connect »

Olathe Medical Center

Olathe, KS United States
  Connect »

Meharry Medical College

Nashville, TN United States
  Connect »

Saint Francis Medical Center

Cape Girardeau, MO United States
  Connect »

Ochsner Medical Center Jefferson

New Orleans, LA United States
  Connect »

Saint Joseph Mercy Hospital

Ann Arbor, MI United States
  Connect »

Saint Cloud Hospital

Saint Cloud, MN United States
  Connect »

Fairbanks Memorial Hospital

Fairbanks, AK United States
  Connect »

Community Cancer Center East

Indianapolis, IN United States
  Connect »

Bay Area Hospital

Coos Bay, OR United States
  Connect »

Mercy Hospital

Coon Rapids, MN United States
  Connect »

Suburban Hospital

Bethesda, MD United States
  Connect »

PCR Oncology

Arroyo Grande, CA United States
  Connect »

Roper Hospital

Charleston, SC United States
  Connect »

Northwest Hospital Center

Randallstown, MD United States
  Connect »

Sinai Hospital of Baltimore

Baltimore, MD United States
  Connect »

Randolph Hospital

Asheboro, NC United States
  Connect »

Mills-Peninsula Medical Center

Burlingame, CA United States
  Connect »

Margaret R Pardee Memorial Hospital

Hendersonville, NC United States
  Connect »

Grand Valley Oncology

Grand Junction, CO United States
  Connect »

Inova Fairfax Hospital

Falls Church, VA United States
  Connect »

Peninsula Cancer Center

Poulsbo, WA United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Northwest Cancer Clinic

Kennewick, WA United States
  Connect »

Island Urology

Honolulu, HI United States
  Connect »

Bay Area Tumor Institute

Oakland, CA United States
  Connect »

Boulder Community Hospital

Boulder, CO United States
  Connect »

University of Virginia Cancer Center

Charlottesville, VA United States
  Connect »

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Mary Washington Hospital

Fredericksburg, VA United States
  Connect »

Saint Luke's Hospital

Chesterfield, MO United States
  Connect »

Elmhurst Memorial Hospital

Elmhurst, IL United States
  Connect »

Sibley Memorial Hospital

Washington, WA United States
  Connect »

Valley Medical Center

Renton, WA United States
  Connect »

Assarian Cancer Center

Novi, MI United States
  Connect »

Anne Arundel Medical Center

Annapolis, MD United States
  Connect »

Decatur Memorial Hospital

Decatur, IL United States
  Connect »

Florida Hospital Orlando

Orlando, FL United States
  Connect »

Freeman Health System

Joplin, MO United States
  Connect »

Mount Sinai Hospital

New York, NY United States
  Connect »

Kaiser Permanente-Oakland

Oakland, CA United States
  Connect »

MetroHealth Medical Center

Cleveland, OH United States
  Connect »

Dekalb Medical Center

Decatur, GA United States
  Connect »

Salinas Valley Memorial

Salinas, CA United States
  Connect »

Illinois CancerCare-Bloomington

Bloomington, IL United States
  Connect »

Adena Regional Medical Center

Chillicothe, OH United States
  Connect »

Condell Memorial Hospital

Libertyville, IL United States
  Connect »