Objective To explore the efficacy and safety of Sacituzumab govitecan on patients with advanced HER2-negative breast cancer.

Methods We classified and analyzed the relevant phase Ⅱ or Ⅲ clinical trials published by May 2021, and used the Stata 12.0 software package for analyzing efficacy and toxicity of Sacituzumab govitecan on the patients with advanced HER2-negative breast cancer.

Results Three studies involving 420 patients with advanced HER2-negative breast cancer were included. Among them, one randomized controlled trial (RCT) study and two cohort studies were conducted. Meta-analysis results showed that total objective response rate of breast cancer to Sacituzumab govitecan was 34%(95%CI: 29.4%-38.6%), and the clinical benefit rate was 45.0%(95%CI: 40.2%-49.8%), the median progression-free survival was 5.59 months (95%CI: 4.95-6.31), the median overall survival was 12.59 months (95%CI: 11.58-13.68), and the median duration of response was 7.40 months(95%CI: 6.23-8.77). The most common serious adverse reactions were neutropenia, anemia, leukopenia, diarrhea, nausea, vomiting, etc. The serious neutropenia, anemia, leukopenia and severe diarrhea should be vigilant.

Conclusion Sacituzumab govitecan can bring significant survival benefits to patients with advanced HER2-negative breast cancer, and severe adverse reactions should be vigilant during use procedure.