A Phase 1 trial to investigate safety profile and immunogenicity of a new breast cancer vaccine developed by Cleveland Clinic may last for a year.
Researches targeting improvement of breast cancers treatment have been going on for years. After two decades of preclinical research, the Phase 1 clinical trial of first ever preventative breast cancer vaccine developed by Cleveland Clinic to prevent triple negative breast cancer (TNBC) has started after receiving approval from the U.S. Food and Drugs Administration (FDA).
A study published in 2010 showed that high levels of protein known as α-lactalbumin are frequently expressed by breast cancer cells, particularly by triple-negative breast cancer cells making them a compelling target for a vaccine. According to some animal studies, the immune system can be trained to target cells that produce α-lactalbumin preventing the growth of breast cancer tumors. The Phase1 human trial of this new vaccine is designed to get more understanding of safety profile of the vaccine and immunological responses. There will be 24 women enrolled for the trials, which will include patients who were earlier diagnosed with triple-negative breast cancer and are free of the disease at present. These participants will be under observation for three months for any contrary effects.
Furthermore, this Phase1 trial will last for around a year. The team plans to enroll more participants to start the evaluation of the efficiency of the vaccine, where the scientists are expecting to enroll cancer-free participants, genetically carrying higher risk of developing breast cancer. Being practical about the long road that lies ahead of the research, the scientists expect that if all the stages of clinical trial run perfectly, it will take at least 10 years to bring the vaccine in the clinical use.
