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Aim:Mitoxantrone is an antineoplastic antibiotic used in the treatment of acute leukemia, lymphoma, prostate and breast cancer. Mitoxantrone Hydrochloride Injection for tracing has a high degree of lymph node tropism by changing the dosage form, which penetrates into lymphatic capillaries through the interstitial space and enriches regional lymph nodes through the gland to stain the lymph nodes blue to achieve lymph node tracing effect. This study is aim to evaluate the efficacy and safety of Mitoxantrone Hydrochloride injection(MHI) for tracing sentinel lymph nodes in patients with early-stage breast cancer.Materials & methods: This study was a phase 3, multicenter, self-controlled, non-inferiority trial designed to assess the efficacy and safety of sentinel lymph node tracing with the investigational drug in patients with early-stage breast cancer. All subjects received MHI combined with Technetium-99m(99mTc-Sc), prior to SLNB. The sentinel node identification rate was compared between MHI and 99mTc-Sc to evaluate non-inferiority and concordance. Results: Data were collected from 381 patients in 6 centers all across China. The SLN detection rate was 96.9% (369/381) when using MHI and 97.4% (371/381) when using the standard technique(Table 1). There was no significant difference in the success rate of SLN detection between the two groups(P > 0.05). Since the lower limit of 95% confidence interval was greater than or equal to -5%, the success rate of SLN detection of MHI was non-inferior to that of 99mTc-Sc. In the combination group, 380 cases (99.5%) were successfully detected with SLN. 202 nodes (13.1%) were detected by the MHI but not by the 99mTc-Sc, and 222 nodes (14.4%) were detected by the 99mTc-Sc but not by the MHI(Table 2). All adverse events recovered within one month after intervention.Conclusion: This prospective, multicenter study has shown the Mitoxantrone Hydrochloride injection for tracing to be non-inferior to the standard technique (99mTc-Sc) for breast SLNB. The Mitoxantrone Hydrochloride injection for tracing can be used alone or combined with radioactive material.Key words:Mitoxantrone Hydrochloride injection(MHI), Tracing, Technetium-99m(99mTc-Sc), sentinel lymph node (SLN), Early-Stage Breast Cancer. Attachments: Table 1.SLN detection rate - comparing the Mitoxantrone Hydrochloride Injection and 99mTc-Sc for TracingSLN detection rates [n (%)]Mitoxantrone Hydrochloride Injection for TracingTotalAt least one node detectedNo nodes detected99mTc-ScPositive361 (94.8%)10 (2.6%)371 (97.4%)Negative8 (2.1%)2 (0.5%)10 (2.6%)Total369 (96.9%)12 (3.1%)381(100%) Table 2.Detected nodes-comparing the Mitoxantrone Hydrochloride Injection and 99mTc-Sc for TracingPer node detection rates [n (%)]Mitoxantrone Hydrochloride Injection for TracingTotalPositiveNegative99mTc-ScPositive869 (56.3%)222 (14.4%)1091 (70.7%)Negative202 (13.1%)251 (16.3%)453 (29.3%)Total1071 (69.4%)473 (30.6%)1544 (100%) Citation Format: Benlong Yang, Dechuang Jiao, Jiajian Chen, Chunjian Wang, Lidan Jin, Wenhe Zhao, Xueqiang Gao, Haibo Wang, Jun Li, Haidong Zhao, Di Wu, Zhiming Fan, Shujun Wang, Zhenzhen Liu, Yongsheng Wang, Jiong Wu. A phase 3, multicenter, self-controlled, non-inferiority trial comparing mitoxantrone hydrochloride injection for tracing versus technetium-99m in the detection of axillary sentinel nodes in patients with early-stage breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-01-10.