Efficacy and Safety of Shen-Ling-Lian-Xia Granule Combined With Neoadjuvant Chemotherapy in Patients With Triple-Negative Breast Cancer: Protocol for a Randomized, Double-Blind, Multicenter Clinical Trial.

Background: Neoadjuvant chemotherapy (NAC) is a crucial component of systemic treatment for triple-negative breast cancer (TNBC), serving as an effective means to reduce recurrence rates and improve survival outcomes. It not only maximizes the extent of resectable tumors but also converts inoperable tumors into operable ones. Shen-Ling-Lian-Xia Granules (SLLXG) is an in-house preparation developed by Longhua Hospital, affiliated with Shanghai University of Traditional Chinese Medicine. Formulated by Professor Liu Sheng, the fifth-generation inheritor of the Shanghai Gu School of Surgery, based on extensive clinical experience treating breast cancer, this compound has been clinically proven to improve postoperative symptoms in patients with TNBC, enhance immunity, reduce recurrence and metastasis, and prolong disease-free survival. However, clinical evidence regarding its efficacy in enhancing the therapeutic effect of NAC for TNBC remains to be established. Objective: This study aims to analyze the impact of SLLXG on the efficacy of NAC for TNBC, evaluate its synergistic effect on NAC, and identify potential beneficiary populations for SLLXG in treating TNBC. It seeks to establish a standardized diagnostic and treatment protocol for broader clinical implementation. Methods: This study will recruit 306 patients diagnosed with TNBC. Patients will be randomly assigned to two groups: one receiving NAC combined with SLLXG treatment, and the other receiving NAC combined with SLLXG placebo treatment. The primary efficacy endpoint was pathological complete response. Secondary efficacy endpoints included objective response rate, clinical benefit rate, Miller-Payne grading for breast cancer, residual cancer burden, peripheral blood lymphocyte levels, stromal tumor-infiltrating lymphocytes in the tumor region stroma, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3.0). Evaluation timepoints will occur after completion of cycles 2, 4, 6, and 8 of NAC. Data will be analyzed using SPSS (version 25.0; IBM Corp) to compare within-group and between-group differences between the 2 cohorts, with a significance level of α=.05 for hypothesis testing. Results: The study was funded in January 2025 and was approved by the Medical Ethics Committee in October 2025. Patient recruitment is scheduled to commence in February 2026. As of January 2026, no patients have been enrolled. The study is expected to conclude data collection by December 2027, with data analysis and final results anticipated for publication in spring 2028. Conclusions: The findings of this study will validate the efficacy of SLLXG in treating TNBC and confirm its synergistic effect on treatment outcomes compared to NAC alone.