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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with stage II-III node-positive breast cancer</li>
<li>Do not have stage IV breast cancer or Clinical N3c breast cancer (clinical N3a and clinical N3b are eligible)</li></ul>
For more information, contact the study team at <a href= "mailto: kennesha.myrick.bragg@duke.edu">kennesha.myrick.bragg@duke.edu.</a>
<li>Are diagnosed with stage II-III node-positive breast cancer</li>
<li>Do not have stage IV breast cancer or Clinical N3c breast cancer (clinical N3a and clinical N3b are eligible)</li></ul>
For more information, contact the study team at <a href= "mailto: kennesha.myrick.bragg@duke.edu">kennesha.myrick.bragg@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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:<ul>
<li><strong>Group A:</strong> 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.</li>
<li><strong>Group B:</strong> 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.</li></ul>
After this procedure, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li><strong>Group A:</strong> 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.</li>
<li><strong>Group B:</strong> 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.</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Maggie
Dinome
Protocol Number
PRO00114419
NCT ID
NCT03513614
Phase
III
Enrollment Status
Open to Enrollment