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Omitting Radiation Therapy for Breast Cancer (TAILOR RT Trial)

Phase 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an Oncotype DX recurrence score ≤25 obtained from testing of breast tumour tissue
Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9.5 years
Awards & highlights

TAILOR RT Trial Summary

This trial is testing whether omitting regional radiation therapy for low-risk breast cancer is non-inferior to usual care.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is examining if skipping regional radiation therapy after usual care (like surgery) prevents breast cancer from returning in low-risk patients as effectively as including it. Women will either receive no radiation or the standard regional radiation to see which approach works best.See study design
What are the potential side effects?
While specific side effects are not listed here, generally speaking, potential side effects from radiation may include skin changes like redness and irritation at the treated area, fatigue due to body's response to treatment, and possible long-term risks such as lymphedema.

TAILOR RT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer recurrence score is 25 or less.
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I agree to provide a tumor tissue sample for research.
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I am a woman newly diagnosed with invasive breast cancer without spread beyond the breast.
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My cancer is large but has not spread to my lymph nodes.
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I have started or am planning to start hormone therapy for at least 5 years.
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My breast cancer recurrence score is 25 or less.
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My cancer is at stage T3N0.
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My cancer has only spread to nearby lymph nodes.
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I had surgery for breast cancer with 1-3 positive lymph nodes.
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I had breast surgery with all cancer removed.
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My cancer is slightly estrogen receptor positive and not HER2 positive.
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I will start radiation therapy within 16 weeks after surgery, or within 12 weeks after my last chemotherapy dose.
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I am willing and able to complete questionnaires in English or French.
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I can start the treatment within 6 weeks after being chosen for the trial.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 35 years old or older.
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I may have had chemotherapy after my main cancer treatment.

TAILOR RT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not
Secondary outcome measures
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 breast cancer mortality between patients that received regional RT or not.
+7 more

TAILOR RT Trial Design

2Treatment groups
Active Control
Group I: Regional RadiotherapyActive Control1 Intervention
A. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy
Group II: No Regional RadiotherapyActive Control2 Interventions
A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
231 Previous Clinical Trials
98,712 Total Patients Enrolled
8 Trials studying Breast Cancer
9,498 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkNETWORK
394 Previous Clinical Trials
263,030 Total Patients Enrolled
53 Trials studying Breast Cancer
63,186 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
65,012 Total Patients Enrolled
8 Trials studying Breast Cancer
6,584 Patients Enrolled for Breast Cancer

Media Library

No Radiation Clinical Trial Eligibility Overview. Trial Name: NCT03488693 — Phase 3
Breast Cancer Research Study Groups: Regional Radiotherapy, No Regional Radiotherapy
Breast Cancer Clinical Trial 2023: No Radiation Highlights & Side Effects. Trial Name: NCT03488693 — Phase 3
No Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03488693 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Other
California
British Columbia
What site did they apply to?
Memorial Sloan Kettering Cancer Center
Parkland Memorial Hospital
BCCA-Vancouver Cancer Centre
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~828 spots leftby Sep 2027