A Phase 3 Study of HER2-Targeted Therapy With and Without Radiation Therapy for Low-Risk Breast Cancer

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Full Title

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO) (NRG-BR008) (CIRB)

Purpose

Researchers want to see if it is safe to forego radiation therapy in some people with breast cancer. The people in this study have breast cancer that makes a protein called HER2 and was removed with lumpectomy. With lumpectomy, only the tumor is taken out. In addition, their cancers have a low chance of coming back after treatment (“low risk”).

Everyone in the study will get HER2-targeted therapy, such as trastuzumab. But only some people will also get radiation therapy. Researchers will compare the rate of relapse between the two groups. If you join this study, you will be randomly assigned to receive HER2-targeted treatment alone or with radiation therapy. HER2-targeted medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have breast cancer that makes HER2 and was removed with lumpectomy (breast-conserving surgery).
  • Have completed at least 12 weeks of chemotherapy plus HER2-targeted therapy.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 40 or older.

Contact

For more information or to see if you can join this study, please call Dr. Diana Roth O’Brien’s office at 201-775-7605.

Protocol

23-135

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05705401