TAILOR-RT for Low-Risk Breast Cancer

What is the 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.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

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

For more information, contact the study team at emily.watson@duke.edu.

Age Group
Adults

What is Involved?

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

Group 2
If you are in this group, you will get regional radiotherapy after your surgery. Your study regimen will be as follows:

  • 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

Study Details

Full Title
TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE AND T3N0 BREAST CANCER
Principal Investigator
Assistant Professor of Radiation Oncology
Protocol Number
IRB: PRO00116773
NCT: NCT03488693
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF