OHSU Knight Cancer Institute

IRB #

STUDY00022257

Title

[NCI CIRB] MA.39 - TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

Principal Investigator

Kiri Cook

Study Purpose

The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy.

Medical Condition(s)

Breast Cancer

Eligibility Criteria

Patient’s age must be ≥ 40 years.

Patient’s life expectancy is ≥ 10 years.

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

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.

Age Range

40 - 99

Healthy Volunteers Needed

Duration of Participation

Treatment will last for up to 6 weeks. Once finished with radiotherapy, patients will be followed until death or study closure.

Minors Included

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503-494-1080

John Minger
mingerj@ohsu.edu
503-494-8756