Cleveland Clinic Phase 1 trial: Preventive vaccine for triple-negative breast cancer shows immune re

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SUMMARY

The Cleveland Clinic, in partnership with Anixa Biosciences, launched a Phase 1 clinical trial in October 2021 for a preventive vaccine against triple-negative breast cancer (TNBC). The vaccine targets alpha-lactalbumin, a protein found in TNBC tumors. Final Phase 1 results, presented in December 2025, showed the vaccine produced an immune response in 74% of participants and was safe and well-tolerated, with mild injection site reactions as the primary side effect. Phase 2 of the trial is expected to begin in late 2026, focusing on vaccine efficacy in preventing recurrence and potentially preventing TNBC in high-risk individuals.

Timeline

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November 2021 — 1 developments

  1. Jennifer Davis among first human participants to receive experimental vaccine in fall 2021

    The first human participants, including Jennifer Davis, began receiving the experimental vaccine in the fall of 2021. [4]

October 2021 — 2 developments

  1. Dr. Thomas Budd discusses triple-negative breast cancer trial and preventive vaccine goal

    Dr. Thomas Budd, principal investigator, discussed the trial's focus on patients with a history of triple-negative breast cancer and the long-term goal of a preventive vaccine for healthy women. [14]

  2. FDA approves investigational new drug application for vaccine, clearing way for clinical trial

    The U.S. Food and Drug Administration (FDA) approved an investigational new drug application for the vaccine, clearing the way for the clinical trial to proceed. [8, 12]