June 16 2021
NRG-BR007: A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score ≤18 Breast Cancer (DEBRA* DE-escalation of Breast RAdiation)
The DEBRA Trial, also known as NRG-BR007, is testing the omission of breast radiation in biologically low risk, hormone-sensitive breast cancer following lumpectomy. This experimental treatment arm (endocrine therapy only) will be compared to the usual standard of care treatment of endocrine therapy and radiotherapy for this patient population.
“Although lumpectomy and radiotherapy has become the accepted standard for breast conserving treatment as an alternative to mastectomy, it is now time to reconsider the additional benefit of radiation in some cases given the ability to identify Stage I, hormone sensitive, HER2-negative breast cancer patients at very low risk of recurrence through subtyping and/or combined with multigene tumor assays like the Recurrence Score. There is a need to address the potential overtreatment of patients with radiation post lumpectomy and recognized barriers of the treatment with regard to toxicity and patient burden,” stated Julia White, MD, the Klotz Chair in Cancer Research at the Ohio State University Comprehensive Cancer Center and the Principal Investigator of the NRG-BR007 trial.
Patients who have had a lumpectomy and have low-risk, early-stage, HER2-negative, ER and/or PgR-positive breast cancer with an Oncotype DX™ Recurrence Score (RS) of less than or equal to 18 will be accrued to this trial. Patients will be stratified by age, RS, and tumor size and will be randomly assigned to one of two treatment arms. Patients on Treatment Arm 1 will receive the standard of care treatment of radiotherapy and endocrine therapy, and patients on Treatment Arm 2 will receive endocrine therapy alone. Researchers on this trial aim to determine if patients only receiving endocrine therapy following their lumpectomy will have the same or better rates of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) when compared to the usual standard treatments.
“Previous research using the Oncotype DX™ Recurrence Score has allowed selected women to safely omit chemotherapy and its associated toxicities from their breast cancer treatment. The DEBRA trial will allow us to assess if the omission of breast radiotherapy can maintain excellent outcomes while reducing the burden and toxicity of treatment for the biologically low-risk patient population we are testing,” added Eleanor Elizabeth Harris, MD, FASTRO, the Director of Breast Cancer Radiation Oncology at the University Hospitals Cleveland Medical Center and the Radiation Oncology Co-Chair of the NRG-BR007 trial.
In addition to the main focus on maintaining a low IBTR in patients, researchers will also evaluate if endocrine therapy following lumpectomy is inclusive of any salvage breast conservation surgery impacts associated with the IBTR rates. The goal of the study is to determine if the experimental treatment results in a non-inferior relapse-free interval, distant disease-free survival, overall survival and overall breast conservation when compared to the usual treatment as well as the difference in patient-reported outcomes between treatment arms.
Health-Related Quality of Life forms will be administered to patients at seven time points during the trial to evaluate whether there is a difference between the two treatment arms in patient-reported breast pain and patient-reported worry about recurrence. Blood and tissue samples will be collected for correlative studies to identify gene expressions or mutations that are associate with breast recurrence and are predictive of radiotherapy toxicity.
Protocol documents and materials are located on the CTSU website.