A Phase III Study Comparing the Usual Treatment of Radiation Therapy and Hormonal Therapy versus Hormonal Therapy Alone for the Treatment of Low-Risk, Early-Stage Breast Cancer

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Full Title

A Phase III Clinical Trial Evaluating DE-escalation of Breast RAdiation (DEBRA) for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer (NRG BR007) (CIRB)

Purpose

People with early-stage breast cancer who undergo lumpectomy have traditionally also received radiation therapy and hormonal (endocrine) therapy to reduce their risk of breast cancer recurrence. Doctors want to know if some patients with low-risk early-stage breast cancer can forgo radiation therapy (which takes several weeks and has side effects) and do as well if they receive only hormonal therapy after lumpectomy.

In this study, researchers will compare the effectiveness of these two treatment approaches in patients with hormone receptor-positive HER2-negative stage I breast cancer that has an Oncotype DX recurrence score of 18 or less. Patients will receive either radiation and hormonal therapy or just hormonal therapy after breast cancer surgery.

Eligibility

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

  • Patients must have stage I breast cancer in one breast only that is positive for estrogen and/or progesterone receptors and negative for HER2 and was surgically removed with lumpectomy within 70 days of entering the study.
  • Patients’ Oncotype DX score must be 18 or less.
  • Patients must have negative lymph nodes under the arm of the affected breast.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients ages 50-70.

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

Protocol

21-283

Phase

III

Investigator

Co-Investigators

Diseases