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Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy

NCT02348320•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This is a phase 1 open-label study to evaluate the safety and immunogenicity of a personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that personalized polyepitope DNA vaccines will be safe for human administration and capable of generating measurable CD8 T cell responses to mutant tumor-specific antigens.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of invasive breast cancer.
•ER and PR less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor. Patients not meeting this pathology criteria, but have been clinically treated as having TNBC, can be enrolled at PI discretion.
•HER2 negative by FISH or IHC staining 0 or 1+.
•Consented for genome sequencing and dbGAP-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing. Fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed

Exclusion Criteria

•At least 18 years of age. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•Adequate organ and marrow function no more than 14 days prior to registration as defined below:
•* WBC ≥ 3,000/μL
•* absolute neutrophil count ≥1,500/μL
•* platelets ≥ 100,000/μL
•* total bilirubin ≤ 2.5 X institutional upper limit of normal
•* AST/ALT ≤ 2.5 X institutional upper limit of normal
•* creatinine ≤ 1.5 X institutional upper limit of normal
•Women of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
•Able to understand and willing to sign an IRB-approved written informed consent document.
+21 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

June 17, 2015

Primary Completion Date

March 12, 2020

Completion Date

March 12, 2020

Last Updated

July 1, 2020

Enrollment

ACTUAL participants

Conditions

Triple Negative Breast CancerTriple-Negative Breast CancerTriple Negative Breast Neoplasms

Interventions

Personalized polyepitope DNA vaccine

BIOLOGICAL

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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Advanced Breast CancerMetastatic Breast Cancer+3 more

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

A Study of LY4175408 in Participants With Advanced Cancer