FDA Approval of Breast Cancer Vaccine

The FDA recently opened the door for a phase 1 of a particular type of breast cancer vaccine to begin this spring. This Phase 1 clinical trial of the vaccine was approved for use in humans with triple negative breast cancer, considered to be one of the most difficult types of breast cancers to treat. As a patient advocate, the FDA approval of the phase 1 clinical trial for this breast cancer vaccine comes as good news.

There are various types of breast cancer. A majority, around 80%, are estrogen receptor positive often referred as ER+. This means the cancer cells grow in response to the hormone estrogen. Women and men who have breast cancers that are ER/PR+ are prescribed medication that blocks the hormone receptors, preventing hormones from binding to them thus helping the breast cancer from coming back.

A pathology report for what type of breast cancer you have should include information about a gene, HER2, that can play a role in the development of breast cancer. HER2 stands for “human epidermal growth factor receptor 2”. The protein associated with the HER2 gene, as well as the estrogen-receptor and progesterone receptors, are lacking in a particular type of breast cancer called triple negative.

Triple-negative breast cancer represents only about 10-20% of breast cancers and why the approval of this clinical trial is good news. The hope of the clinical trial is to produce a vaccine that will reduce the incidence of this rare type of breast cancer.

It will take a number of years to move through the process and phases of the clinical trial for usage of the vaccine. The work is being done at the Cleveland Clinic by a team of experts including lead researcher, Dr. Vince Vincent Tuohy, PhD. and staff physician Dr. George Thomas Budd, MD.

This clinical trial will include men. Male breast cancer represents about 1% of all breast cancers. This is important information and good news for the male breast cancer community.

Forthcoming Work with the Breast Cancer Vaccine

Triple negative breast cancer is more prevalent in the younger (under 50) population, Black and Hispanic population, and those with a BRCA1 mutation. There is great hope with the FDA approval of this clinical trial for this breast cancer vaccine targeting triple negative breast cancer. Much work will be done over the next few years to determine the dose and number of doses needed, as well as how long the immunity response will be last for those receiving the vaccine. Clinical trials must be conducted with great precision and care.

This vaccine is being developed to ultimately prevent breast cancer rather than treat it. The clinical trial is being funded by the U.S. Department of Defense. For further information you can follow, Clinical Trials.gov or email: Canceranswer@ccf.org and Josette is the contact at this email.

When you open the Clinical Trials.gov site look specifically for the Cleveland Clinic trial for triple negative breast cancer.

FDA Approval of Breast Cancer Vaccine

Disclaimer

References made to my surgical group, surgeon and healthcare team are made because they are aligned with my values and met my criterion after I did research of their practices and success rates. Any other healthcare provider that displays the same skill, compassion education and outreach to patients will be given consideration and recognition on this website.  The information contained on this website is not a substitute for or should be construed as medical advice. Please consult a licensed physician for medical advice.