Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. We have both interventional & observational types of clinical trials found on this site.
Breast cancer is among the most common types of cancer in the world. Factors such as age, reproduction, nutrition, hormonal, and lifestyle factors also play a role in the etiology of breast cancer. Nutrition can affect cancer metabolism at stages such as carcinogen metabolism, cell, and host defense, cell differentiation, and tumor growth. When investigating nutrition and breast cancer risk, it is important to evaluate the preparation and cooking processes applied to foods. Advanced glycation end products (AGE) are formed as a result of heat treatment applied to foods. There are studies showing that AGEs increase inflammation and oxidative stress in the organism. It is aimed to compare the dietary AGE intake and serum levels of AGE participants with breast cancer and healthy participants and to examine the relationship with serum inflammatory, oxidative stress, DNA damage, and total antioxidant capacity. Patients with breast cancer will be evaluated before surgery, before chemotherapy, and in the sixth and twelfth months after starting chemotherapy. The amount the dietary AGE intake, serum markers, nutritional status, and changes in quality of life will be determined.
This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.
Chemotherapy is an important means to prolong the survival time of advanced breast cancer. As a new type of microtubule inhibitor, eribulin has a unique mechanism of action. Compared with single drug chemotherapy, it can improve the overall survival time of 2.5 months, increase the clinical benefit rate by 5 times, and the tolerance of eribulin is good. Therefore, the guidelines at home and abroad recommend eribulin for the rescue of advanced breast cancer. However, up to now, there is no large sample data on the efficacy of eribulin combined with anti HER2 targeted therapy in HER2 + metastatic breast cancer, and the efficacy of combined immunotherapy in triple negative metastatic breast cancer. Moreover, as a newly marketed chemotherapy drug in China, the efficacy and safety data of eribulin in Chinese population are relatively lacking. Therefore, we plan to include different types and line numbers of advanced breast cancer patients based on the Chinese population through real-world research, and receive the treatment regimen containing eribulin respectively. In HR + / her2-mbc, we use eribulin monotherapy; in HER2 + MBC, we use eribulin + anti HER2 targeted therapy; in TNBC, we use eribulin + immunotherapy / chemotherapy, The efficacy and safety of eribulin were evaluated.