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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

Must not have

Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy

Synchronous or previous contralateral invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9.5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

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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I had surgery for breast cancer with 1-3 positive lymph nodes.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer or DCIS on the same side treated with radiation before.

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I have had breast cancer in both breasts, either at the same time or at different times.

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I have had radiation therapy on the same side of my chest before.

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I have a serious illness that prevents me from receiving radiation therapy.

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I do not have any serious health issues that would stop me from following the study's requirements.

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I received chemotherapy or hormone therapy before surgery for breast cancer.

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My cancer has only spread to nearby lymph nodes.

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My cancer is in an advanced stage, affecting nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 20Eligibility criteria met