biostudies-literatureLiu JGuangzhou Science and Technology ProgramNational Natural Science Foundation of ChinaSun Yat-Sen Clinical Research Incubation ProgramSun Yat-Sen Clinical Research 5010 Programe078049https://www.ebi.ac.uk/biostudies/studies/S-EPMC11293409biostudies-literatureUnknown14(7)<h4>Introduction</h4>Postoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1-2N1M0 cohort with a low clinical risk of local-regional recurrence (LRR), has incited a discourse surrounding personalised treatment strategies. Multigene testing for Recurrence Index (RecurIndex) model capably differentiates patients based on their level of LRR risk. This research aims to validate whether a more aggressive treatment approach can enhance clinical outcomes in N1 patients who possess a clinically low risk of LRR, yet a high RecurIndex-determined risk of LRR. Specifically, this entails postoperative whole breast irradiation combined with regional lymph node irradiation (RNI) following breast-conserving surgery or chest wall irradiBMJ open<u>R</u>ecur<u>I</u>ndex-<u>G</u>uided postoperative radiotherapy with or without <u>A</u>voidance of <u>I</u>rradiation of regional <u>N</u>odes in 1-3 node-positive breast cancer (RIGAIN): a study protocol for a multicentre, open-label, randomised controlled prospective, phase III trial.PMC1129340982173232SYS-C-202006SYS-5010-202303Liu JZhang ADChen JLiang ZZhang NWang FLin XZhou WHou YLan XYe XHuang SZhao LDing RTan YZhang XGuo JGHuang XWang XWang YXu XBi Zfalse<u>R</u>ecur<u>I</u>ndex-<u>G</u>uided postoperative radiotherapy with or without <u>A</u>voidance of <u>I</u>rradiation of regional <u>N</u>odes in 1-3 node-positive breast cancer (RIGAIN): a study protocol for a multicentre, open-label, randomised controlled prospective, phase III trial.<h4>Introduction</h4>Postoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1-2N1M0 cohort with a low clinical risk of local-regional recurrence (LRR), has incited a discourse surrounding personalised treatment strategies. Multigene testing for Recurrence Index (RecurIndex) model capably differentiates patients based on their level of LRR risk. This research aims to validate whether a more aggressive treatment approach can enhance clinical outcomes in N1 patients who possess a clinically low risk of LRR, yet a high RecurIndex-determined risk of LRR. Specifically, this entails postoperative whole breast irradiation combined with regional lymph node irradiation (RNI) following breast-conserving surgery or chest wall irradi2024-01-01T00:00:00Z2024 Jul2026-06-03T00:37:51.049Z2024-11-15T21:24:02.582ZS-EPMC112934093907992110.1136/bmjopen-2023-078049