Omitting Radiation Therapy for Breast Cancer
(TAILOR RT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that endocrine therapy should be initiated or planned for at least 5 years, and it can be given concurrently or following radiation therapy.
Is it safe to omit radiation therapy for breast cancer?
Omitting radiation therapy in older women with early-stage estrogen-receptor-positive breast cancer who are receiving endocrine therapy is considered safe based on trial data. Efforts are ongoing to minimize long-term side effects of radiation, and some studies suggest that omitting radiation in certain cases does not increase the risk of cancer recurrence.12345
How does omitting radiation therapy differ from other breast cancer treatments?
Omitting radiation therapy for breast cancer is unique because it involves not using radiation after breast-conserving surgery, especially in older women with early-stage, hormone-receptor-positive breast cancer, if they are receiving hormone therapy. This approach is considered acceptable for certain patients and aims to reduce the side effects associated with radiation, while still maintaining effective cancer control.36789
What data supports the effectiveness of omitting radiation therapy for breast cancer?
The research indicates that while radiation therapy reduces local recurrence and improves survival in many breast cancer cases, there is uncertainty about its benefits for patients receiving modern systemic therapy, especially in those with high-risk features but no lymph node involvement. This suggests that omitting radiation might be considered in specific patient groups, although more evidence is needed to confirm this approach.410111213
Who Is on the Research Team?
Timothy Whelan
Principal Investigator
Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada
Are You a Good Fit for This Trial?
This trial is for women over 35 with early-stage breast cancer that hasn't spread, specifically T3N0 or limited nodal micrometastases. They should have an Oncotype DX score ≤25, be ER ≥1% and HER2 negative, and can start treatment within 6 weeks of joining the study. Participants must not be pregnant, have serious illnesses preventing protocol adherence, or a history of certain cancers within the last 5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either regional radiotherapy or no regional radiotherapy, along with standard care including endocrine therapy and possibly chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of arm volume, mobility, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- No Radiation
- Radiation
No Radiation is already approved in European Union, United States for the following indications:
- Early-stage breast cancer with specific criteria (e.g., T1N0, grade 1-2 tumors, estrogen receptor-positive)
- Early-stage breast cancer with specific criteria (e.g., T1N0, grade 1-2 tumors, estrogen receptor-positive), particularly in older women or those with low-risk features
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborator
SWOG Cancer Research Network
Collaborator
Southwest Oncology Group
Collaborator
Eastern Cooperative Oncology Group
Collaborator
NRG Oncology
Collaborator