[Progress of clinical trials on breast cancer in China, 2011-2022].
Objective: To systematically summarize the research progress of clinical trials on breast cancer drugs in China from 2011 to 2022, as well as provide an overview of the marketed drugs. The goal is to offer data and decision-making evidence for relevant departments. Methods: Based on the registration database of the China National Medical Products Administration's Clinical Trial Registration and Information Disclosure Platform, as well as data from the domestic and imported drug query systems, an analysis was conducted on clinical trials of breast cancer drugs, including information on investigational drugs and marketed drugs from January 1, 2011, to December 31, 2022. The study compared differences between Chinese and foreign enterprises in terms of trial scope, trial phases, number of treatment lines, drug types, and mechanisms of action. Results: From 2011 to 2022, a total of 401 clinical trials for breast cancer were registered in China, accounting for 8.0% of the country's overall anti-tumor clinical trials (401/5 011), with 304 trials (75.8%) initiated by domestic enterprises. Over the past decade, clinical trials for breast cancer showed fluctuating growth, reaching a peak of 84 trials in 2020. These trials involved 254 drugs, with 156 (61.4%) being original drugs and 174 (68.5%) being targeted therapies. The most focused targets included human epidermal growth factor receptor 2 (HER-2), cyclin-dependent kinases 4/6 (CDK4/6), and estrogen receptors (ER). There are 50 drugs targeting HER-2 (28.7%), 35 targeting CDK4/6 (20.1%), and 31 targeting ER (17.8%). During the period from 2011 to 2022, a total of 15 drugs for treating breast cancer were approved and launched in China, covering 19 indications. Among these, 7 indications are for adjuvant or neoadjuvant therapy of early-stage breast cancer, and 12 indications are for advanced breast cancer. Conclusions: Substantial achievements have been made in the development of new breast cancer drugs in China from 2011 to 2022. However, there remains a significant gap in the innovation capabilities of domestic pharmaceutical companies compared to international counterparts in the field of breast cancer. Future efforts should be directed towards strengthening research and development in breast cancer, exploring new target points, and investigating combination therapy mechanisms.