TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Study on Regional Radiotherapy in Low Risk Node Positive Breast Cancer

Y
Yunjie Lin, MD

Primary Investigator

R
Richard Zellars, MD

Primary Investigator

Enrolling By Invitation
40 years - 100 years
Female
Phase N/A
7 Locations

Brief description of study

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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

This study has two study groups.
•    Group 1 will get no regional radiotherapy as follows:
o    If you had surgery to remove part of the breast (called breast conserving surgery), you will receive radiation aimed at the breast only (whole breast radiation).
o    If you had surgery to remove the whole breast (called mastectomy) you will receive no radiation therapy.

•    Group 2 will get the usual treatment for this type of cancer, regional radiotherapy, as follows:
o    If you had surgery to remove part of the breast, you will receive radiation aimed at the breast only (whole breast radiation) and additional radiation aimed at the surrounding lymph glands (regional radiation).
o    If you had surgery to remove the whole breast you will receive radiation aimed at the chest area and the surrounding lymph glands (regional radiation).
A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others.

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 40 years - 100 years
  • Gender: Female

Inclusion Criteria
  • Patients must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases
  • Patients must have been treated by BCS or mastectomy
  • Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm)
  • Patients treated by BCS and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm)
  • Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node (macrometastases, > 2 mm)
  • Patients must be ER ≥ 1% and HER2 negative on local testing
  • Patients must have an Oncotype DX recurrence score <18
  • Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted
  • Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted
  • Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Endocrine therapy can be given concurrently or following RT.
  • Patients may or may not have had adjuvant chemotherapy
  • RT must be administered within 12 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 2-8 weeks after the last dose
  • Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months.

 
Exclusion Criteria
  • Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and ≤ 2 mm) or isolated tumour cells (pN0i+ < 0.2 mm)
  • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  • Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS not treated with radiation are eligible.)
  • History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years
  • Patients with pT3 or pT4 disease
  • Patients who are pregnant
  • Patients that have had prior ipsilateral chestwall/thoracic radiation
  • Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer
  • Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT
  • Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision)

Updated on 03 Sep 2025. Study ID: BALL-CCTG-MA39, 0000000000;27711

This study investigates the effects of receiving regional radiotherapy compared to no regional radiotherapy in patients with low risk node positive breast cancer. Breast cancer is a disease where cells in the breast grow uncontrollably. This study includes two study arms. In one arm, participants who had breast conserving surgery will receive radiation aimed only at the breast, while those who had a mastectomy will receive no radiation. In the other arm, participants will receive the usual treatment, which includes additional radiation aimed at the lymph glands.

Participants will be randomly assigned to one of the study arms, which means a computer will decide which treatment they will receive by chance. This process is called randomization. The study will involve procedures like radiation therapy, which uses high-energy rays to kill cancer cells. Participants will not know which group they are in, and neither will the doctors. This is to ensure that the study results are fair and unbiased.

  • Who can participate: Adults with newly diagnosed invasive breast cancer, treated with either breast conserving surgery or mastectomy, can participate. They must have 1-3 positive axillary nodes, be ER positive, HER2 negative, and have an Oncotype DX recurrence score less than 18. Women of childbearing potential must use effective contraception.
  • Study details: Participants will be assigned by chance to receive either regional radiotherapy or no regional radiotherapy. Those receiving regional radiotherapy will have radiation aimed at the breast and lymph glands. A placebo is not used in this study.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only