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

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

May 31, 2026

Conditions
Pathologic Stage IIA-IIIC Triple-Negative Breast CancerTNBC - Triple-Negative Breast CancerResidual 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)"

Trial Locations (1)

44915

Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Anixa Biosciences, Inc.

UNKNOWN

lead

George T. Budd

OTHER