Tailored Axillary Surgery in Node-Positive Breast Cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if radiation to the axillary (armpit) lymph nodes is equally effective and causes fewer side effects than surgical removal of the lymph nodes in patients with breast cancer.
What is the Condition Being Studied?
Breast Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with stage II-III node-positive breast cancer
- Do not have stage IV breast cancer or Clinical N3c breast cancer (clinical N3a and clinical N3b are eligible)
For more information, contact the study team at kennesha.myrick.bragg@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will have the lymph node with known cancer removed as well as sentinel nodes, to see if other lymph nodes also have cancer. Sentinel nodes are the first few lymph nodes to which cancer generally spreads.
After this procedure, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group A: If you are in this group, your remaining axillary (armpit) lymph nodes will be surgically removed. This corresponds to the standard treatment, which can effectively prevent recurrences in the armpit. However, about a quarter of people experience side effects, some of which are permanent.
- Group B: If you are in this group, your armpit will be irradiated without removing the remaining lymph nodes. Radiotherapy to the armpit is given at the same time as radiotherapy to the breast or chest, which is planned procedure for participants in both groups.
Study Details
Full Title
Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS). A multicenter randomized phase III trial.
Principal Investigator
Surgical Oncologist
Protocol Number
IRB:
PRO00114419
NCT:
NCT03513614
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment