Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

TNBC - Triple-Negative Breast Cancer Clinical Trial

Official title: Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.

Clinical Trial Description

This is an open-label, phase I dose-escalation trial that will be performed on three successive cohorts. The first cohort is comprised of participants with high-risk triple-negative breast cancer. The second is made up of participants scheduled to undergo bilateral prophylactic mastectomy due to their genetic risk of triple-negative breast cancer. The third cohort is comprised of participants who have had treatment for their triple-negative breast cancer treatment, receiving adjuvant pembrolizumab. These cohorts will be treated with successively higher doses of α-lactalbumin and zymosan.

This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).

A traditional "3+3" Phase I trial design will be employed for the cohorts to determined the Maximum Tolerated Dose (MTD). After identification of the MTD, if at least 1 participant has an immunologic response (correlative measurement), successively lower dose levels will be expanded to a total of 6 participants and immunologic response assessed. Enrollment will stop if a dose level is reached for which no responses are observed. Dose-Limiting toxicities (DLTs) in 2 or more of 6 participants, the next lower dose will be considered the new MTD.

Objectives are to determine MTD, DLT incidence, and Lowest Immunologic Dose (LID) for each cohort.

Toxicity will be assessed every 2 weeks until day 56 and at day 84 or at off-study. Participants will be offered participation in long-term follow-up involving contact or in-person follow-up for late toxicity and survival every 3 months for 2 years, every 6 months for an additional 3 years, and then annually for 10 years. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Residual Disease
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04674306
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Contact: George T Budd, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch@ccf.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 1, 2021
• Completion date: March 1, 2025