A Study Assessing the Need for Regional Radiation Therapy in Women with Low-Risk Breast Cancer

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Full Title

CCTG MA.39 TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (CIRB)

Purpose

Women with breast cancer that has spread to the lymph nodes normally have hormonal therapy and chemotherapy to help prevent the cancer from coming back. Many women will also receive radiation therapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). It is not known, however, if patients with low-risk breast cancer need regional radiotherapy. As a result, some women may be getting regional radiotherapy without needing it, exposing them to the side effects of this treatment without benefit.

The purpose of this study is to find out if women with low-risk breast cancer need regional radiotherapy. This study will help researchers learn whether some patients with breast cancer in the lymph glands can safely forego regional radiotherapy. Patients will be randomly assigned to receive conventional regional radiotherapy or no regional radiotherapy.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must have breast cancer that was surgically treated with lumpectomy or mastectomy and has spread to the lymph nodes.
  • Patients must have a low risk of breast cancer recurrence, as determined by the OncoType DX test, which your radiation oncologist can order.
  • Patients may not have received prior radiation.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 40 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Lior Braunstein at 201-775-7446.

Protocol

19-410

Phase

Phase III (phase 3)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT03488693