October 14 2025
NRG-BR007 (DEBRA): A Phase III Clinical Trial Evaluating the De-escalation of Breast Radiation for a More Conservative Treatment of Patients With Low-Risk, Hormone-Sensitive, Node-Negative Breast Cancer
NRG-BR007 trial is currently enrolling patients with stage I (T1N0), hormone-sensitive, HER-2 negative, oncotype recurrence score (RS) <18 breast cancer who have undergone a lumpectomy with histologically clear margins. These patients will be entered into the trial and randomized into one of two arms — Arm 1: radiation therapy and endocrine therapy versus Arm 2: endocrine therapy alone — in order to evaluate whether treatment with endocrine therapy alone results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) in comparison to a treatment including radiotherapy. Secondary objectives will compare relapse-free interval (RFI), distant disease-free survival (DDFS), and overall survival (OS), as well as patient-reported breast pain, worry about recurrence, and patient adherence to treatment between the two arms. Post lumpectomy breast radiation using standard methods (Hypo- or conventionally fractionated whole breast irradiation with or without boost, Accelerated Partial Breast Irradiation, or Partial Breast Irradiation are permitted. The type of endocrine therapy (tamoxifen or aromatase inhibitor) is at the physician’s discretion and for at least 5 years. Read more
The following study tools are available for the NRG-BR007/DEBRA study:
NRG-BR009 (OFSET): A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)
Currently enrolling patients, NRG-BR009 is a Phase III randomized trial for premenopausal women with pN0-1, ER-positive and HER2-negative breast cancer. The primary aim of the study is to determine whether adjuvant chemotherapy added to OFS + AI (ovarian function suppression plus aromatase inhibitor) is superior to OFS + AI in improving invasive breast cancer-free survival (IBCFS) in premenopausal women with 21-gene recurrence score between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). The study is pragmatic, and the therapy options include standard of care commonly used chemotherapy regimens in those patients randomized to chemotherapy and with ovarian suppression, there is freedom in agent used and dosing schedule. The assessments of adverse events are particularly focused on those side effects seen with estrogen deprivation. Monitoring of estradiol levels is recommended to assure optimal ovarian function suppression. Read more
The following study tools are available for the NRG-BR009/OFSET study: