Breakthrough Breast Cancer Vaccine Begins Human Trials

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With Pinktober ending just recently, news of a possible life-changing vaccine against breast cancer comes as a welcome surprise!

After two decades in development, a vaccine created to prevent breast cancer will now be undergoing its first human trials! Developed by the Cleveland Clinic, this groundbreaking vaccine was designed to target a specific protein (α-lactalbumin) commonly produced by triple-negative breast cancers, which amount to 15% of all breast cancer cases.

Triple-negative breast cancers are so named due to the lack of one of the three main molecular characteristics usually targeted by typical treatment methods, making them particularly deadly.

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“The general idea behind the vaccine is that α-lactalbumin could be a so-called immunologic target – where we can stimulate the immune system to attack cells that make that protein,” said G. Thomas Budd, the principal investigator on the trial.

Preceding this particular development, various studies have been conducted investigating triple-negative breast cancer that include animal trials that have revealed how training the immune system to target α-lactalbumin-producing cells can slow down the growth of tumors, or even prevent them from occurring in the first place.

“What we’re trying to do is what we call primary intervention,” said Vincent Tuohy – the primary inventor of the vaccine who has worked on developing it for nearly two decades. “It’s actually preventing the disease from occurring – it was never there to begin with.”

“We’re not trying to prevent recurrence,” he added. “We’re trying to prevent the emergence of the tumor and prevent it from ever happening.”


Receiving approval by the U.S Food and Drug Administration (FDA), vaccine trials will finally get to be tested on humans. The trial’s first phase will be administered on 18 to 24 patients who are tumor-free, have already completed treatment for early-stage triple-negative breast cancer within the past three years, but who are also at high-risk for recurrence of the cancer.

If the first phase of testing proves successful, trials will then proceed forward to treating cancer-free women with a high risk of developing the disease. This includes BRCA1 gene mutations that develop breast tumors classed as triple-negative breast cancer 70 to 80% of the time.

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“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,” said Budd.

“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.”


If proven successful, Tuohy adds that such vaccine strategies could very well be applied to other types of tumors.

“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.”

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