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1 de nov. de 2023 · The SOUND trial was a prospective multicenter noninferiority phase 3 randomized clinical trial conducted in 18 hospitals in Italy, Spain, Switzerland, and Chile (eTable in Supplement 2). Participants were recruited and enrolled from February 6, 2012, to June 30, 2017.
1 de nov. de 2023 · Intervention: Eligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group). Main outcomes and measures: The primary end point of the study was distant disease-free survival (DDFS) at 5 years, analyzed as intention to treat.
Gentilini OD, Botteri E, Sangalli C, et al; SOUND Trial Group. Sentinel lymph node biopsy vs no axillary surgery in patients with small breast cancer and negative results on ultrasonography of axillary lymph nodes: the SOUND randomized clinical trial.
21 de sept. de 2023 · In this randomized clinical trial that included 1463 women with small node-negative BC, patients who did not undergo axillary surgery had noninferior 5-year distant disease–free survival compared with those who underwent sentinel lymph node biopsy.
Editorial. To the Editor We read the results of the SOUND randomized clinical trial by Gentilini et al 1 with great interest. The authors demonstrated the noninferiority of omission of axillary surgery for patients with sentinel lymph node biopsy (SLNB) with clinically node-negative small breast cancer.
28 de feb. de 2024 · The Sentinel Node versus Observation after Axillary Ultrasound (SOUND) trial was a prospective, multi-national noninferiority phase 3 study, which randomized patients with a negative preoperative axillary ultrasound (US) to sentinel lymph node biopsy (SLNB) or no axillary surgery, prior to breast conserving surgery (BCS). 1 Patients with SLN met...
6 de dic. de 2023 · The SOUND (Sentinel node versus Observation after axillary ultra-soUND) randomized trial 1 was conceived right after the ground-breaking data of the Z-0011 trial 2 had demonstrated that there was no oncological benefit to performing axillary lymph node dissection (ALND) after breast-conserving therapy when the sentinel lymph node was involved.
