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These studies suggest that breast-conserving surgery alone is non-inferior to breast-conserving surgery plus radiotherapy for in-breast recurrence and breast preservation in women with stage 1 breast cancer intending to undergo endocrine therapy.
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Stage 1a breast cancer is characterized by small tumors (up to 2 cm) that have not spread to lymph nodes or distant sites. The majority of these cases are hormone receptor-positive (ER/PR-positive) and HER2-negative, which influences treatment decisions and prognosis .
Genomic assays, such as Oncotype DX, play a crucial role in assessing the risk of recurrence and guiding treatment decisions for stage 1a breast cancer. These assays help identify patients with a low risk of distant metastasis who may not benefit from chemotherapy, thereby sparing them from unnecessary toxicity . The Oncotype DX Recurrence Score (RS) is particularly useful in predicting local-regional recurrence (LRR) and guiding the de-escalation of adjuvant therapies .
The NRG-BR007 trial is a significant study exploring the possibility of de-escalating radiotherapy in patients with stage 1a breast cancer who have undergone breast-conserving surgery (BCS). The trial hypothesizes that BCS alone, followed by endocrine therapy (ET), is non-inferior to BCS plus RT in terms of in-breast recurrence (IBR) and breast preservation . Patients are stratified by age, tumor size, and RS, and randomized to receive either RT plus ET or ET alone .
Eligible patients for the NRG-BR007 trial are those aged 50 to 70 years with stage 1a breast cancer (pT1, pN0), ER/PR-positive, HER2-negative, and an Oncotype DX RS of ≤18. The primary endpoint is IBR, while secondary endpoints include breast conservation rate, invasive in-breast recurrence, relapse-free interval, distant disease-free survival, overall survival, patient-reported breast pain, and worry about recurrence .
The potential to omit RT in selected patients could significantly reduce treatment burden and improve quality of life without compromising outcomes. The trial aims to demonstrate that the omission of RT is non-inferior, with a clinically acceptable difference in IBR of 4% at 10 years . This approach aligns with the broader goal of personalized medicine, where treatment is tailored based on individual risk profiles.
The ongoing research, particularly the NRG-BR007 trial, is pivotal in shaping the future management of stage 1a breast cancer. By leveraging genomic assays to stratify risk and potentially de-escalate treatment, clinicians can offer more personalized and less toxic treatment options to patients. The results of these studies are eagerly awaited and could lead to significant changes in clinical practice, emphasizing the importance of individualized care in breast cancer treatment.
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