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

Clinical Trial Details

This study is for patients who have breast cancer that has spread to the lymph nodes under the arm (in the arm pit) and have been treated with chemotherapy. These patients may or may not have already undergone surgery to remove the breast cancer and sample the lymph nodes. 

Patients with this type of breast cancer usually have neoadjuvant (which means given before surgery) chemotherapy followed by breast and arm pit surgery to remove any remaining breast cancer. The lymph nodes in the arm pit are examined during surgery and if there is still cancer in the lymph nodes, then the majority of lymph nodes in the arm pit are removed. 

The purpose of this study is to examine whether removing some of the lymph nodes from the arm pit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the arm pit removed during breast surgery followed with radiation (standard of care). 

If the patient is randomized to the treatment group called “Arm 1” more lymph nodes from the arm pit will be removed (this is called axillary lymph node dissection). If the patient is randomized to this treatment group after the surgery to examine lymph nodes, the patient will have another surgery to remove more lymph nodes from the arm pit (axillary lymph node dissection). The patient will begin radiation therapy treatments 3 to 12 weeks after surgery. The radiation treatments will be given 5 days a week over 5 – 6 weeks. 

If the patient is assigned to the treatment group called "Arm 2” the patient will not have any more lymph nodes removed. The patient will begin radiation therapy treatments 3 to 12 weeks after surgery. The radiation treatments will be given 5 days a week over 5 – 6 weeks. 

Key Eligibility: 
  • Age 18 years or older 
  • Breast cancer that has spread to the lymph nodes under the arm (in the arm pit) and treated with chemotherapy 
  • Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Marta Vallee Cobham, RN, BSN
(212) 821-0780
mac2034@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1901019939

ClinicalTrials.gov:

NCT01901094

Sponsor:

A011202

Status

Not Yet Recruiting

Age Group

Adult

Sponsor