Finn's Take· TL;DRChase Johnson's dog saved her life in the most unexpected way. When the 31-year-old's pet began acting strangely—anxious, clingy, and eventually pushing his nose directly into her breast—she discovered a hard lump that would change everything. When Chase Johnson was 31, her dog began acting strange. He was anxious, wouldn't leave her side and, one day, pushed his nose into the side of her breast. Johnson felt a hard lump.
"I wasn't someone who was good at doing self-exams, I don't think I would have found it otherwise," Johnson, now 36, of Cary, North Carolina, said. Her diagnosis in February 2021 revealed triple-negative breast cancer, one of the most aggressive forms of the disease. Johnson was diagnosed in February 2021 with triple-negative breast cancer, an aggressive type of the disease that tends to grow quickly and spread to other parts of the body.
Rather than accepting conventional treatment alone, Johnson enrolled in a groundbreaking clinical trial at Cleveland Clinic that could revolutionize cancer prevention. "I am literally doing anything possible to make sure this doesn't come back," Johnson said.
The experimental vaccine targets a protein called alpha-lactalbumin, which normally exists only in lactating breast tissue but appears in approximately 70% of triple-negative breast cancers. The vaccine targets a protein called α-lactalbumin, which is present in about 70% of triple-negative breast cancers and found on the surface of tumor cells. "Alpha-lactalbumin is a milk protein, so it's normally made by a lactating breast, so women who are breastfeeding. But in other tissues at other times, it's very rare to see this, if at all."
The concept, known as the "retired protein hypothesis," exploits the fact that this protein should no longer exist in non-lactating women. If successful, the vaccine would teach the immune system to make T-cells that attack and destroy cells with the protein. The immune system can be trained to recognize and eliminate cancer cells before they develop into dangerous tumors.
Results from the Phase 1 trial, presented at the San Antonio Breast Cancer Symposium, exceeded expectations. The researchers found that 74% of the women developed an immune response to the vaccine — though what that result means for reducing recurrence or preventing disease is still unknown. Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and elicited protocol-defined immune responses in 74% of participants.
Triple-negative breast cancer represents a particularly urgent medical challenge. Triple-negative breast cancer accounts for only 10-15% of breast cancer cases, but causes a disproportionately high number of deaths, according to the American Cancer Society. The disease is twice as common in Black women and represents 70-80% of breast tumors in patients with BRCA1 gene mutations.
Unlike other breast cancers, this subtype lacks the biological targets that make hormonal and targeted therapies effective. Unlike other breast cancers, it lacks biological characteristics that respond to hormonal or targeted therapies. "For triple negative, the resources are so limited; if the traditional treatment methods don't work, you're just kind of out of luck."
The trial studied three distinct groups: women like Johnson who had recovered from early-stage disease but remained at high risk for recurrence, women with remaining tumor cells after treatment, and women with genetic predispositions like BRCA mutations who hadn't yet developed cancer. This comprehensive approach suggests the vaccine could serve both treatment and prevention purposes.
While the immune response data is encouraging, researchers emphasize that larger studies are needed to determine actual effectiveness. "Whether this immune response will translate into reducing the risk of recurrence or preventing breast cancer, we don't know that yet," said trial leader Dr. G. Thomas Budd, a breast cancer medical oncologist at Cleveland Clinic's Cancer Institute. A phase II study to see how effective the vaccine is is expected to begin in late 2025 or early 2026.
The research builds on decades of work by the late Dr. Vincent Tuohy, whose vision extended beyond breast cancer. "It was Dr. Tuohy's hope that this vaccine would demonstrate the potential of immunization as a new way to combat breast cancer, and that a similar approach could someday be applied to other types of malignancies," said Dr. Johnson. Cleveland Clinic researchers have recently received grants to develop a vaccine for Ewing sarcoma. "I'm very optimistic that one or more of these are going to be a benefit to our patients."
The approach represents a paradigm shift from treating cancer after it develops to preventing it entirely. If successful, this vaccine could transform how we approach not just triple-negative breast cancer, but potentially other aggressive cancers that exploit similar biological vulnerabilities.