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

NCT04674306 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-17

Study results available
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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.

Conditions

  • Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer
  • TNBC - Triple-Negative Breast Cancer
  • Residual Disease

Interventions

BIOLOGICAL

α-lactalbumin vaccine

α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy). DL1: 10 mcg DL Original 2: 100 mcg DL2: 100 mcg DL3: 500 mcg D1b: 50 mcg D1e: 10 mcg D1f: 20 mcg D1g: 20 mcg (D1g will only be utilized if D1c is deemed too toxic)

BIOLOGICAL

Zymosan

Adjuvant used in vaccine preparation DL1: 10 mcg DL Original 2: 100 mcg DL2: 10 mcg DL3: 10 mcg D1b: 10 mcg D1e: 20 mcg D1f: 20 mcg D1g: 1o mcg (D1g will only be utilized if D1c is deemed too toxic)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Anixa Biosciences, Inc.

    collaborator UNKNOWN

  • George T. Budd

    lead OTHER

Principal Investigators

  • George T Budd, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2025-12-15
Completion
2025-12-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674306 on ClinicalTrials.gov