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Alliance A011202 (Breast Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if removing some lymph nodes (but not all) from the arm pit, followed with radiation therapy will be as good as the standard treatment of having most of the lymph nodes removed from the arm pit during breast surgery followed with radiation therapy.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

Adults with breast cancer who:
- Have spread to the lymph nodes
- Had an axillary ultrasound and biopsy
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have an examination of your lymph nodes during surgery
-- If your lymph nodes have cancer in them, you will be randomized (put into one of two groups by chance like the flip of a coin) and get either:
--- Group 1: More lymph nodes are removed during surgery and you will have radiation therapy
--- Group 2: Radiation therapy
- Have a physical exam every 6 months for the first 2 years, then every year for 3-5 years after your radiation therapy is complete

Study Details

Full Title
Alliance A011202: 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
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00051624
NCT:NCT01901094
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698