Prevention (STEMVAC vaccine, sargramostim) for Anatomic Stage IIA Breast Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Wisconsin Carbone Cancer Center, Madison, WI
Anatomic Stage IIA Breast Cancer AJCC v8+18 More
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Eligible Conditions

  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage 2 Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Triple Negative Breast Carcinoma
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anatomic Stage IIA Breast Cancer AJCC v8

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Month 1
Incidence of adverse events
13 months
Kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts
Month 10
Cellular immune response: incidence
Cellular immune response: magnitude
Prior to and after STEMVAC vaccination
Activation status and repertoire diversity of peripheral blood T-cells
Up to 5 years
Relapse free survival (RFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Anatomic Stage IIA Breast Cancer AJCC v8

Trial Design

1 Treatment Group

Prevention (STEMVAC vaccine, sargramostim)
1 of 1
Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Prevention (STEMVAC vaccine, sargramostim) · No Placebo Group · Phase 2

Prevention (STEMVAC vaccine, sargramostim)Experimental Group · 2 Interventions: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2011
Completed Phase 4
~730

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: University of Wisconsin Carbone Cancer Center · Madison, WI
Photo of madison  1Photo of madison  2Photo of madison  3
2016First Recorded Clinical Trial
3 TrialsResearching Anatomic Stage IIA Breast Cancer AJCC v8
71 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have HER2 expression by IHC or FISH.
You must have completed standard of care systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment.
Treatment with a bisphosphonate or denosumab to prevent bone loss is not considered to be systemic therapy for breast cancer and its use within the 28 day pre-enrollment period or while on study is not exclusionary.
You must agree to avoid systemic steroids for the duration of the treatment period and until completion of the 1 month post 2nd booster vaccine visit (end of treatment).
You must be at least 18 years of age.\n
Participants must have ECOG performance status score of =< 1.
You have lymphocyte count > 800/mm^3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.