RECRUITING

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Trial of The Immunogenicity of a DNA Plasmid Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDC25B, CD105) in Participants With Early Stage Triple Negative Breast Cancer

Quick Facts

Study Start:2022-11-17

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05455658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as: * 0-1+ HER2 expression by immunohistochemistry (IHC) OR * Fluorescence in situ hybridization (FISH) negative OR * HER2 2+ and FISH negative * Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation. * Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment * Participants 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) * Participants must be at least 18 years of age * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 * White blood cell (WBC) \>= 3000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Lymphocyte count \>= 800/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Platelet count \>= 100,000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Hemoglobin (Hgb) \>= 10 g/dl (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Serum creatinine =\< 1.2 mg/dl OR creatinine clearance \> 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Total bilirubin =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * AST (aspartate aminotransferase)/serum glutamic-oxaloacetic transaminase (SGOT) =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment * The effects of STEMVAC on the developing human fetus are unknown. For this reason, * Female participant agrees to use adequate contraception (examples include: estrogen and/or progestogen containing hormonal contraception, barrier method (condom, cervical cap) or abstinence) while on the study and until 1 month after the 2nd booster vaccination when/if engaging in sex that could lead to pregnancy. Exceptions: Females who have had a hysterectomy, tubal ligation or bilateral oophorectomy OR meet one of the following criteria for postmenopausal: Age \> 60 or age \< 60 with \>= 12 months amenorrhea and follicle-stimulating hormone (FSH) within the testing facility's postmenopausal range * Female participant agrees to inform her study physician immediately should she become pregnant or suspect she is pregnant while participating in this study * Male participants who are having sex that can lead to pregnancy must use an acceptable form of contraception (vasectomy with the absence of sperm, sexual abstinence, condoms) throughout the course of the study * Must be 14 days between a vaccine (i.e. COVID19, Flu, shingrix, Tdap, etc.) and any STEMVAC vaccination. \\Note: This does not apply to the Td vaccine. * Patients must be willing to not undergo major elective surgical procedures with general anesthesia or conscious sedation through the end of treatment visit. (Note: port removal is allowable) * Ability to understand and the willingness to sign a written informed consent document	* Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products * History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC * Participants receiving any other investigational agents * Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days * Participants with any clinically significant autoimmune disease uncontrolled with treatment * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and breastfeeding women are excluded from this study * Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C * Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.) * History of invasive breast cancer prior to TNBC diagnosis \* Note: Prior DCIS is allowable

Inclusion Criteria

Exclusion Criteria

* Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as:
* 0-1+ HER2 expression by immunohistochemistry (IHC) OR
* Fluorescence in situ hybridization (FISH) negative OR
* HER2 2+ and FISH negative
* Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation.
* Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment
* Participants 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)
* Participants must be at least 18 years of age
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
* White blood cell (WBC) \>= 3000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Lymphocyte count \>= 800/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Platelet count \>= 100,000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Hemoglobin (Hgb) \>= 10 g/dl (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Serum creatinine =\< 1.2 mg/dl OR creatinine clearance \> 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Total bilirubin =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* AST (aspartate aminotransferase)/serum glutamic-oxaloacetic transaminase (SGOT) =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment)
* Must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment
* The effects of STEMVAC on the developing human fetus are unknown. For this reason,
* Female participant agrees to use adequate contraception (examples include: estrogen and/or progestogen containing hormonal contraception, barrier method (condom, cervical cap) or abstinence) while on the study and until 1 month after the 2nd booster vaccination when/if engaging in sex that could lead to pregnancy. Exceptions: Females who have had a hysterectomy, tubal ligation or bilateral oophorectomy OR meet one of the following criteria for postmenopausal: Age \> 60 or age \< 60 with \>= 12 months amenorrhea and follicle-stimulating hormone (FSH) within the testing facility's postmenopausal range
* Female participant agrees to inform her study physician immediately should she become pregnant or suspect she is pregnant while participating in this study
* Male participants who are having sex that can lead to pregnancy must use an acceptable form of contraception (vasectomy with the absence of sperm, sexual abstinence, condoms) throughout the course of the study
* Must be 14 days between a vaccine (i.e. COVID19, Flu, shingrix, Tdap, etc.) and any STEMVAC vaccination. \*\*Note: This does not apply to the Td vaccine.
* Patients must be willing to not undergo major elective surgical procedures with general anesthesia or conscious sedation through the end of treatment visit. (Note: port removal is allowable)
* Ability to understand and the willingness to sign a written informed consent document

* Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC
* Participants receiving any other investigational agents
* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days
* Participants with any clinically significant autoimmune disease uncontrolled with treatment
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant and breastfeeding women are excluded from this study
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.)
* History of invasive breast cancer prior to TNBC diagnosis \* Note: Prior DCIS is allowable

Contacts and Locations

Study Contact

Kim Mast

CONTACT

608-263-8606

mast2@wisc.edu

Jennifer Childs, MPH

CONTACT

206-616-2305

childj@uw.edu

Principal Investigator

Mary Disis, MD

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Howard Bailey, MD

STUDY_DIRECTOR

University of Wisconsin, Madison

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287

United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: University of Washington

Mary Disis, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium
Howard Bailey, MD, STUDY_DIRECTOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-17

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-11-17

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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