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New vaccine targets triple-negative cases, result brings hope


A new vaccine targeting triple-negative breast cancer (TNBC), one of the most hard-to-treat types, has shown early promise in a Phase 1 clinical trial. Read inside.


Published date india.com
Published: December 15, 2025 2:24 PM IST

Breakthrough in breast cancer care: New vaccine targets triple-negative cases, result brings hope
Breakthrough in breast cancer care: New vaccine targets triple-negative cases, result brings hope
What if the body could be trained to fight one of the deadliest forms of breast cancer before it returns? That question is now closer to being answered. Triple-negative breast cancer is considered one of the most difficult forms of breast cancer. This type of cancer, TNBC, does not have estrogen receptors (ER), progesterone receptors (PR), or HER2 protein expression, resulting in ineffective use of treatment and hormone-targeted therapies. As a result, treatment options are limited, recurrence rates are high, and long-term outcomes are often poor.

However, the good news in that there is hope. Researchers from the Cleveland Clinic have shared encouraging results from a Phase 1 clinical trial of a new vaccine designed to activate the immune system against TNBC. The findings were presented at the San Antonio Breast Cancer Symposium. The results show a potential new approach for preventing and treating this aggressive cancer.

How Does the Vaccine Work?

The investigational vaccine targets alpha-lactalbumin (aLA), a protein that is normally active in breast tissue only during lactation. However, this protein is also found in many triple-negative breast cancer tumours. By training the immune system to recognise and attack cells expressing aLA, the vaccine aims to eliminate emerging cancer cells or prevent recurrence.

Key Findings from Phase 1 Trial

The Phase 1 study focused primarily on safety, tolerability, and immune activation, rather than long-term clinical outcomes like survival or recurrence. As per the data, approximately 74% of participants developed a measurable immune response after receiving the vaccine. This means their immune systems produced T cells specific to alpha-lactalbumin, indicating successful immune activation.

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The vaccine was also found to be safe for the recommended dose. Some of the side effects included were mild and included local skin inflammation at the injection site, which, as per researchers, is a common and expected immune reaction. Fortunately, there were no serious adverse events.

Who Took Part in the Study?

Participants were divided into three groups:

Patients who had completed early-stage TNBC treatment and were tumour-free but at high risk of recurrence
Individuals at high genetic risk for breast cancer who had opted for preventive mastectomy
Early TNBC patients who had residual disease after chemo-immunotherapy and surgery

A total of 35 participants received the investigational vaccine.

What Happens Next?

As per experts, this finding is the first step toward a vaccine-based strategy for TNBC. While Phase 1 trials do not measure long-term efficacy, the strong immune activation and no adverse side effects have generated hope.

Larger Phase 2 and Phase 3 trials will be needed to confirm whether this immune response translates into reduced recurrence and improved survival. Future studies may also examine combining the vaccine with existing treatments like checkpoint inhibitors to enhance immune activation.

Why This Matters

Globally, TNBC accounts for about 10 to 15% of all breast cancers, yet it causes a disproportionate number of breast cancer-related deaths. If successful, this vaccine could mark a major shift in how aggressive breast cancers are prevented and treated, offering new hope to patients who currently have limited options.






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