We might soon have a cure for triple-negative breast cancer
12 Dec 2025

Researchers at the Cleveland Clinic have developed a new vaccine aimed at preventing recurrences of triple-negative breast cancer (TNBC), one of the most aggressive and difficult-to-treat forms of the disease.

The Phase 1 clinical trial involved 35 women to test both safety and immune response stimulation by the vaccine.

The results were promising, with 74% of participants showing an immune response.

Vaccine's immune response and safety profile
Trial details

The Phase 1 trial included three groups of women: those at high risk of recurrence but tumor-free after early-stage TNBC treatment, those with residual tumor cells after treatment, and genetically predisposed women without a breast cancer diagnosis.

The vaccine was generally well-tolerated by participants with only mild side effects such as redness or lumps at the injection site being reported.

No serious adverse events were observed during the trial.

Concerns and future trials
Autoimmune risk

Despite the positive results, there are concerns about a potential autoimmune reaction where the body's immune system could attack its own tissues.

This is because the vaccine targets a-lactalbumin, a protein produced by women during breastfeeding.

The researchers have advised against enrolling women who plan to breastfeed into this trial due to these concerns.

Phase 2 trials and long-term plans
Next steps

The trial, funded by the US Department of Defense, began in 2021.

While the initial results are promising, it is still too early to determine if the vaccine will prevent cancer or its recurrences.

The researchers plan to conduct Phase 2 trials to test its effectiveness. This next phase is tipped to begin late next year and could take two to three years.