Phase 1 trial launched investigating vaccine for triple-negative breast cancer


Preclinical data shows this investigational vaccine’s potential in preventing triple-negative breast cancer and inhibiting existing tumor growth.

The Cleveland Clinic has announced the launch of its phase 1 trial investigating a novel vaccine aimed at preventing triple-negative breast cancer, which is the most lethal and aggressive form of breast cancer.

The object of the phase 1 trial is to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer, as well as characterize and optimize the body’s immune response, according to a press release announcing the phase 1 trial.1

Most recently, the US Food and Drug Administration has approved an investigational new drug application for the vaccine, allowing Cleveland Clinic and Anixa Biosciences, Inc to commence the study.2

“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 G. Thomas Budd, MD, Taussig Cancer Institute, Cleveland Clinic, and principal investigator of the study. “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.”

This novel vaccine specifically targets a breast lactation protein, α-lactalbumin, a protein not found in post-lactation in normal, aging tissues. However, this protein has been found in most triple-negative breast cancers. The vaccine aims to activate the immune system against this protein to provide pre-emptive immunity against breast tumors that express α-lactalbumin. Additionally, the vaccine consists of an adjuvant that activates an immune response allowing the immune system to initiate a response against any emerging tumors to prevent them from growing.

“This vaccine approach represents a potential new way to control breast cancer,” said Vincent Tuohy, PhD, staff immunologist at the Cleveland Clinic’s Lerner Research Institute, and primary inventor of the vaccine. “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.” 

The launch of the phase 1 clinical trial is backed by pre-clinical research conducted by Tuohy that showed activating the immune system against α-lactalbumin was both safe and effective in preventing breast tumors in mice. Pre-clinical data also found a single vaccination could prevent breast tumors from forming in mouse models, while simultaneously inhibiting the growth of existing breast tumors.

The phase 1 trial funded by the US Department of Defense, will enroll 18 to 24 patients at the Cleveland Clinic who have completed treatment for early-stage triple-negative breast cancer within the past 3 years and are currently tumor-free but at high risk for recurrence. 

During the study, participants will receive 3 vaccinations, 2 weeks apart and will be monitored for any side effects and immune response. Cleveland Clinic estimates this study will be completed in September 2022.

A subsequent trial anticipated by researchers will study healthy, cancer-free women at high risk for developing breast cancer who have also decided to undergo voluntary bilateral. Normally, these patients carry mutations in either the BRCA1 or BRCA2 gene and are at an increased risk of developing triple-negative breast cancer or have a high familial risk for any form of breast cancer.

“This vaccine strategy has the potential to be applied to other tumor types,” said Tuohy. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. 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.”


Tuohy is listed as inventor of the vaccine, which Cleveland Clinic exclusively licensed to Anixa Biosciences, Inc. Cleveland Clinic says we will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and holds personal equity in the company.


1. Releases N. Cleveland clinic launches first-of-its-kind preventive breast cancer vaccine study. Cleveland Clinic Newsroom. Published October 26, 2021. Accessed October 27, 2021.

2. Inc AB. Anixa biosciences and cleveland clinic announce fda clearance to initiate clinical trial of breast cancer vaccine. Accessed October 27, 2021.

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