Cleveland Clinic announces next step in preventive breast cancer vaccine study

• The clinical trial will study cancer-free people at high risk of developing breast cancer.

9 February 2023, Cleveland: Cleveland Clinic researchers have taken the next step in their novel study of a vaccine designed to prevent triple-negative breast cancer, the most aggressive and lethal form of the disease.

Funded by the U.S. Department of Defense, the new phase 1b study will enrol cancer-free people at high risk of developing breast cancer who have voluntarily decided to undergo a prophylactic mastectomy to reduce their risk.

People in this category usually carry genetic mutations that put them at risk of developing triple-negative breast cancer or have a high family risk of any type of breast cancer. The study, conducted at Cleveland Clinic’s main campus, will assess safety and monitor immune response.

The new study will include approximately 6 to 12 patients and is expected to be completed by the end of 2023. Study participants will receive three vaccinations given two weeks apart and will be closely monitored for side effects and immune response.

The phase 1b clinical trial, conducted in partnership with Anixa Biosciences, Inc., follows the ongoing phase 1a study, which opened in 2021 and is expected to conclude in the fourth quarter of 2023. The phase 1a trial includes patients who completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumour-free but at high risk of recurrence.

“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd, M.D., of the Taussig Cancer Institute at Cleveland Clinic and the study’s principal investigator. “Long term, we are hoping that this can be a true preventive vaccine that would be given to cancer-free individuals to prevent them from developing this highly aggressive disease.”

According to Dr. Budd, there is a great need for better treatments for triple-negative breast cancer, which lacks biological features that typically respond to hormonal or targeted therapies. Despite accounting for only about 12% to 15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths. It is twice as likely to occur in Black women, and approximately 70% to 80% of breast tumours in women with mutations in the BRCA1 gene are triple-negative breast cancer.

The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Lerner Research Institute at Cleveland Clinic. Dr. Tuohy was a prominent and passionate scientist whose decades of pioneering research led to the development of this investigational vaccine.

The vaccine targets a lactation protein, α-lactalbumin, which is no longer found after lactation in normal, ageing tissues but is present in most triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumour and keep it from growing.

The study is based on Dr. Tuohy’s research showing that activating the immune system against α-lactalbumin was safe and effective in preventing breast tumours in mice. The research, originally published in Nature Medicine, was funded in part by philanthropic donations from more than 20,000 people over the past 12 years.

“It was Dr. Tuohy’s hope that this vaccine would demonstrate the potential of immunisation as a new way of controlling breast cancer, and that a similar approach could one day be applied to other types of malignancy,” added Dr. Budd.

For more information and eligibility requirements, visit clinicaltrials.gov.

---

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical centre that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based on the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States.  

U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 72,500 employees worldwide are more than 5,050 salaried physicians and researchers, and 17,800 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties.  Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 21 hospitals, more than 220 outpatient facilities, and locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England.

 In 2021, there were 10.2 million outpatient visits, 304,000 hospital admissions and observations, and 259,000 surgeries across Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries.  

Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

Find out more about AF Comunicación Estratégica and its clients