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Protocol No. A011202

Principal Investigator Anderson, Bethany

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Objective 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).

Treatment If cancer is found in the sentinel lymph nodes, you will be "randomized" into one of the two study groups described below. The randomization may take place during the surgery or it may take place after the surgery is completed. Randomization means that you are put into a group by chance. A computer program will place you in one of the two study groups. Neither you nor your doctor can choose the group you will be in. You will have an equal chance of being placed in either group. If you were randomized during the surgery, you will not know which treatment you were assigned to until after the surgery.

Description If you are randomized to the treatment group called "Arm 1" more lymph nodes from your arm pit will be removed. If you are randomized to this treatment group after the surgery to examine your lymph nodes, you will have another surgery to remove more lymph nodes from your arm pit. You will begin your radiation therapy treatments 3 to 12 weeks after surgery. The radiation treatments will be given 5 days a week over 5 - 6 weeks. If you are assigned to the treatment group called "Arm 2" you will not have any more lymph nodes removed. You will begin your 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
  • Clinical stage T1-3 N1 M0 breast cancer at diagnosis
  • No inflammatory breast cancer
  • Patients must have had estrogen receptor, progesterone receptor and HER2 status evaluated on diagnostic core biopsy prior to start of chemotherapy
  • Patients with HER-2 positive tumors must have received trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy before surgery
  • No history of prior or concurrent contralateral invasive breast cancer. Benign breast disease, LCIS or DCIS of contralateral breast is allowed.

Applicable Disease Sites Breast

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics