Tailored Axillary Surgery in Node-Positive Breast Cancer

Tailored Axillary Surgery in Node-Positive Breast Cancer

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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:
  • 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 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?

Description

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.

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