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Omitting Radiation Therapy for Breast Cancer (TAILOR RT Trial)
TAILOR RT Trial Summary
This trial is testing whether omitting regional radiation therapy for low-risk breast cancer is non-inferior to usual care.
TAILOR RT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTAILOR RT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TAILOR RT Trial Design
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Who is running the clinical trial?
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- My breast cancer recurrence score is 25 or less.I agree to provide a tumor tissue sample for research.I am a woman newly diagnosed with invasive breast cancer without spread beyond the breast.My cancer is large but has not spread to my lymph nodes.I have started or am planning to start hormone therapy for at least 5 years.I had breast surgery with all cancer removed, and my cancer was in one or more spots in the same breast.My breast cancer recurrence score is 25 or less.My cancer is at stage T3N0.I have had breast cancer or DCIS on the same side treated with radiation before.I have had breast cancer in both breasts, either at the same time or at different times.I have had cancer other than breast cancer, but it was treated over 5 years ago with no current signs of the disease.I have had radiation therapy on the same side of my chest before.I have a serious illness that prevents me from receiving radiation therapy.I do not have any serious health issues that would stop me from following the study's requirements.My cancer has only spread to nearby lymph nodes.I had surgery for breast cancer with 1-3 positive lymph nodes.I received chemotherapy or hormone therapy before surgery for breast cancer.I had breast surgery with all cancer removed.My cancer is slightly estrogen receptor positive and not HER2 positive.I will start radiation therapy within 16 weeks after surgery, or within 12 weeks after my last chemotherapy dose.I am willing and able to complete questionnaires in English or French.I can start the treatment within 6 weeks after being chosen for the trial.The patient must give consent for the blood samples to be taken so that the specific correlative marker assays can be conducted.I may or may not have had chemotherapy after my initial cancer treatment.My cancer has only spread to nearby lymph nodes.My cancer is in an advanced stage, affecting nearby lymph nodes.I can take care of myself and am up and about more than half of my waking hours.My cancer has only spread to nearby lymph nodes.I am 35 years old or older.I may have had chemotherapy after my main cancer treatment.My cancer has only spread to nearby lymph nodes.
- Group 1: Regional Radiotherapy
- Group 2: No Regional Radiotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there different sites where this research is being carried out?
"Enrollment for this study is currently happening at Aspirus Regional Cancer Center in Wausau, Wisconsin, LDS Hospital in Salt Lake City, Utah, Smilow Cancer Hospital Care Center - Guiford in Guilford, Connecticut as well as 100 other sites."
What is the fatality rate of Regional Radiotherapy?
"Radiotherapy has been deemed safe by our team, as it is a Phase 3 trial with some data supporting efficacy and multiple rounds of safety data."
Are we still recruiting participants for this research project?
"The available information suggests that this trial is still recruiting patients. It was originally posted on 5/30/2018, with the most recent update being on 10/17/2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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