Cleveland Clinic begins trial for breast cancer vaccine

US researchers hope to safeguard women against triple-negative breast cancer, which has the least effective treatments

A laboratory worker involved in the breast cancer vaccine experiment. Photo: Cleveland Clinic

Scientists in the US have begun a trial to produce a vaccine that could prevent millions of women from developing the deadliest form of breast cancer.

Cleveland Clinic has started a Phase 1 trial to determine whether a preventative shot could be given to stop the development of triple-negative breast cancer.

Despite representing about 12 per cent to 15 per cent of all breast cancers, it accounts for a disproportionately higher percentage of deaths and has a higher rate of recurrence. Triple-negative does not have biological characteristics that typically respond to hormonal or targeted therapies.

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

This vaccine approach represents a potential new way to control breast cancer

Dr Vincent Tuohy,
Lerner Research Institute, Cleveland Clinic

“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.”

Dr Tuohy is named as inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences.

The US Food and Drug Administration recently approved an investigational new drug application for the vaccine, which permits Anixa and Cleveland Clinic, which has a large hospital branch in Abu Dhabi, to begin.

The trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to optimise the body’s immune response.

“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 Dr Thomas Budd of Cleveland Clinic’s Taussig Cancer Institute and principal investigator of the study.

Young cancer survivors given three vaccine shots

About one in eight women will develop invasive breast cancer in their lifetime, and some will be diagnosed with triple-negative.

Triple-negative breast cancer is twice as likely to occur in African-American women, and approximately 70 per cent to 80 per cent of the breast tumours that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

Funded by the US Department of Defence, the new study at Cleveland Clinic will include 18 to 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.

Participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed in September 2022.

Researchers anticipate that a subsequent trial will involve healthy, cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. Typically, those women carry mutations in either the BRCA1 or BRCA2 gene and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer.

“This vaccine strategy has the potential to be applied to other tumour types,” Dr Tuohy said.

“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 programme has had.”