The first-ever human trials aimed at testing a vaccine against the ‘most aggressive and lethal form’ of breast cancer are set to begin.
The announcement comes during Breast Cancer Awareness Month, with the Cleveland Clinic hoping to develop a shot to fight triple-negative breast cancer, a particularly deadly variation of the disease that can only be treated with a mastectomy.
While there have been a number of studies into triple-negative vaccines in lab work and animal trials, this novel study is the first of its kind after the US Food and Drug Administration recently approved an investigational new drug application for the vaccine.
The phase one trial will include 18-24 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumour-free but at high risk for recurrence.
If successful, the researchers hope to move onto cancer-free women at high risk. For example, women with BRCA1 gene mutations who later have breast tumours suffer from triple-negative breast cancer 70% to 80% of the time.
‘We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,’ G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study, said in a press release.
‘Long term, we are hoping that this can be a true preventive vaccine that would be administered to healthy women to prevent them from developing triple-negative breast cancer, the form of breast cancer for which we have the least effective treatments.’
Triple-negative breast cancer accounts for 12-15% of all breast cancers – however, its death rate is significantly higher. ‘This vaccine approach represents a potential new way to control breast cancer,’ Vincent Tuohy, Ph.D., primary inventor of the vaccine and staff immunologist at the institute, also said.
‘The long-term objective of this research is to determine if this vaccine can prevent breast cancer before it occurs, particularly the more aggressive forms of this disease that predominate in high-risk women.’
Tuohy also said the vaccine strategy could potentially be ‘applied to other tumour types… if successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had’.
The study is set to be completed by September 22.
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Topics: Health, Breast Cancer, Cancer, Cleveland, medicine, Now, US, Vaccines