α-lactalbumin vaccine for Pathologic Stage IIA-IIIC Triple Negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pathologic Stage IIA-IIIC Triple Negative Breast Cancer+4 More
α-lactalbumin vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new vaccine to treat triple negative breast cancer, which is a difficult to treat form of the disease. They are testing to see if it is safe and what the most effective dose is.

Eligible Conditions
  • Pathologic Stage IIA-IIIC Triple Negative Breast Cancer
  • Residual Disease
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pathologic Stage IIA-IIIC Triple Negative Breast Cancer

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day 84

Day 84
Lowest Immunologic Dose (LID) of α-lactalbumin vaccine
MTD of α-lactalbumin vaccine

Trial Safety

Safety Progress

1 of 3

Other trials for Pathologic Stage IIA-IIIC Triple Negative Breast Cancer

Trial Design

1 Treatment Group

α-lactalbumin and zymosan
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: α-lactalbumin vaccine · No Placebo Group · Phase < 1

α-lactalbumin and zymosanExperimental Group · 2 Interventions: α-lactalbumin vaccine, Zymosan · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 84

Who is running the clinical trial?

George T. BuddLead Sponsor
United States Department of DefenseFED
767 Previous Clinical Trials
202,211 Total Patients Enrolled
George T Budd, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Primary tumor must be ER-negative (ER in <1% of cells), PR-negative (PR in <1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio<2.
Treatment prior to enrollment must be consistent with contemporary NCCN guidelines, found at: https://www.nccn.
The prolactin level must be < ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.