Title
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast cancer

Description
Phase III, Tailor Radiation Therapy: Low Risk Node Positive Breast Cancer

Objective
The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy to low risk breast cancer patients. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from coming back as good as giving regional radiotherapy

Treatment
Group 1 will get no regional radiotherapy as follows:

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)

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:

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)

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)

Key Eligibility
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

Patients treated by BCS and SLNB alone must have only 1-2 positive axillary nodes

Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node

Patients must be ER greater than or equal to 1% and HER2 negative on local testing

Patients must have an Oncotype DX recurrence score less than 18

Patients must have had endocrine therapy initiated or planned for greater than or equal to 5 years. Endocrine therapy can be given concurrently or following RT

Patients may or may not have had adjuvant chemotherapy

ECOG performance status must be 0, 1 or 2, Patient s age must be greater than or equal to 40 years, life expectancy is greater than or equal to 10 years

Women of childbearing potential must have agreed to use an effective contraceptive method

EXCLUSION:

Patients with nodal disease limited to micrometastases or isolated tumour cells

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 any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections

Applicable Disease Sites
Breast

Participating Institutions
Bellin Memorial Hospital/Cancer Team at Bellin Health; Johnson Creek, UW Cancer Center; UW Health Carbone Cancer Center Rockford; UW Health Eastpark Medical Center; UW Health University Hospital