Regional Radiation Therapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Official Title

TAILOR RT: A Randomized Trial of Regional Radiation Therapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Summary:

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Trial Description

Primary Outcome:

• compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not

Secondary Outcome:

• Compare the invasive disease-free survival between patients that received regional RT or not.
• Compare the breast cancer mortality between patients that received regional RT or not.
• Compare the overall survival (OS) between patients that received regional RT or not
• Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not.
• Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not.
• Number and severity of adverse events using the current CTCAE version 4
• Compare arm volume and mobility measurements between patients that received regional RT or not
• Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not
• Compare the quality of life (QOL) between patients that received regional RT or not
• Compare the cost-effectiveness between patients that received regional RT or not
• Compare the quality of life (QOL) between patients that received regional RT or not
• Compare the quality of life (QOL) between patients that received regional RT or not

Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiation therapy to the whole breast/chest area and the surrounding lymph glands (called regional radiation therapy). No one really knows whether patients with low risk breast cancer need to receive regional radiation therapy. Some women may be getting regional radiation therapy who do not need it. These women may be exposed to the side effects of their treatment without benefit.

View this trial on ClinicalTrials.gov