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(H2NVAC) for Ductal Carcinoma (HER2Vaccine Trial)

Phase 1 & 2

Recruiting

Led By Amy C Degnim

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

HER2Vaccine Trial Summary

This trial will study a vaccine to prevent breast cancer in patients who have been diagnosed with a precancerous condition. The goal is to see if the vaccine is safe and effective.

HER2Vaccine Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Dose limiting toxicities

HER2Vaccine Trial Design

1Treatment groups

Experimental Treatment

Group I: GM-CSF and H2NVAC vaccineExperimental Treatment1 Intervention

GM-CSF Dose and route: 125 mcg admixed with vaccine; intradermal injection Every 14 days ± 2 days for a maximum of 4 cycles H2NVAC vaccine 4 peptides, at dose level as shown below, admixed with GM-CSF; intradermal injection. Every 14 days ± 2 days for a maximum of 4 cycles

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,041 Total Patients Enrolled

Amy C DegnimPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

43 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of individuals enrolled in this clinical investigation?

"Indeed, clinicaltrials.gov indicates that this medical research is actively searching for participants. The trial was initiated on May 1st 2019 and has since been modified as recently as July 7th 2021. 43 patients are required from two distinct healthcare sites."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Confirmed. Patient recruitment for this medical trial is ongoing; the study was first uploaded to clinicaltrials.gov on May 1st, 2019 and last updated July 7th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Multi-epitope HER2 Peptide Vaccine in Patients With HER2-expressing DCIS

Amy C. Degnim 2019. "Neoadjuvant Multi-epitope HER2 Peptide Vaccine in Patients With HER2-expressing DCIS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03793829.