A011202 Axillary Radiation vs Axillary Lymph Node Dissection

A011202 - A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Morales, Leticia

    Trial Phone: 321.841.6696

  • IRB No: A011202

    Protocol Abbrev: A011202

    Principal Investigator: Terry P. Mamounas, MD

    Sub Investigators: Baidas, Said MD; Moroose, Rebecca MD; Rostorfer, Regan MD; Shah, Nikita MD

    Age Group: Adult

    Secondary Protocol No: A011202

    Treatment: Surgery

    Applicable Disease Sites: Breast

    Therapies Involved: Procedure: Axillary Lymph Node Dissection Radiation: Nodal Radiation Therapy Radiation: Axillary Radiation Therapy

    ClinicalTrials.gov ID: NCT01901094

  • 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 patients with a positive sentinel lymph node after completion of neoadjuvant chemotherapy

  • Key Eligibility

    Must have pathologically or histologically proven malignant axillary lymph nodes prior to neoadjuvant therapy.