Researchers at Cleveland Clinic have launched the next phase of their evaluation of a novel breast cancer vaccine that prevents triple-negative breast cancer (TNBC). Triple-negative breast cancer is the most aggressive form of the disease, accounting for roughly 10-15% of all breast cancers.
The new phase 1b study will enroll cancer-free women at high risk of developing breast cancer
who have volunteered to undergo a prophylactic mastectomy to lower their risk.
Of all the different forms of breast cancer, triple-negative disease has the fewest treatment options. Triple-negative tumors do not have estrogen or progesterone receptors (ER or PR) and don’t make any or much of the protein called HER2. For these reasons, hormone therapy and anti-HER2 drugs are not options for women with TNBC, leaving chemotherapy as the mainstay of treatment. African American patients under the age of 40 who have BRCA1 mutation are more likely to develop these cancers.
TNBC differs from other forms of invasive breast cancer in that it has fewer treatment options and tends to have a worse prognosis.
The signs and symptoms of TNBC are similar to other types of breast cancer. According to the American Cancer Society, the most common symptoms are:
The breast cancer vaccine is developed to treat a-lactalbumin. The study shows that this lactation protein is produced when a woman is lactating or preparing for lactation. However, a healthy body stops producing the protein as lactation ends and a patient ages.
As the tumor grows, patients with triple-negative breast cancer tend to keep producing this protein. About 70% of patients with this type of breast cancer have this biomarker. In the presence of a-lactalbumin, the vaccine stimulates the immune system, causing the body to attack the tumor and prevent further spread.
The study is closely related to a current phase 1a study that began in 2021 and includes women who have received an earlier treatment for triple-negative breast cancer. Researchers estimate to have both phase 1a and 1b studies completed by the end of 2023.
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There was some good news for patients with triple-negative breast (TNBC) cancer recently. Following extensive review, the US Food and Drug Administration (FDA) approved the immunotherapy drug Keyturda for treatment for early TNBC in combination with chemotherapy.
Triple-Negative breast cancer accounts for about 10-20% of all breast cancers. TNBC is not fueled by estrogen, progesterone, or the HER2 protein like most other breast cancer types. This means TNBC does not respond to hormone therapy.
Keytruda (pembrolizumab) is classified as an immunotherapy and is used a lot in the medical field to treat other forms of cancers. Immunotherapy is a type of biological therapy that triggers your own immune system to attack disease. Immunotherapy drugs have been approved to treat many types of cancer. However, it is not used as frequently as traditional treatment options such as surgery, chemotherapy, or radiation therapy, or more typically, a combination of these.
Trial data from over 1,000 patients showed that Keytruda, in combination with chemotherapy before surgery and then used as a monotherapy after surgery, helped prolong “event-free survival”. This combination therapy using immunotherapy is the first of its kind to be approved for patients with early-stage TNBC by the FDA.