Purpose of this Study
We are doing this study to find out if it is better to give patients with low-risk breast cancer regional radiation therapy as part of their standard treatment after surgery or if it is better to not give radiation. Regional radiotherapy is currently the standard treatment after surgery for low-risk breast cancer but we do not know if it is necessary in all cases.
Who Can Participate?
Eligibility
Women ages 35+ who:
- Are newly diagnosed with invasive carcinoma of the breast that has no evidence of metastases
- Have or will be treated with breast-conserving surgery or mastectomy with clear margins
Age Range
35-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups.
Group 1
If you are in this group, you will not get regional radiotherapy. Your study regimen will be as follows:
- If you have surgery to remove part of the breast (called breast conserving surgery), you will receive radiation aimed at the breast only (whole breast radiation); OR
- If you have surgery to remove the whole breast (called mastectomy), you will receive no radiation therapy
- If you have breast conserving surgery, you will get whole breast radiation and additional radiation aimed at the surrounding lymph nodes (regional radiation); OR
- If you have a mastectomy, you will receive regional radiation aimed at the chest area and the surrounding lymph nodes
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE AND T3N0 BREAST CANCER
Principal Investigator
Susan
McDuff
Protocol Number
PRO00116773
NCT ID
NCT03488693
Phase
III
Enrollment Status
Pending Open to Enrollment