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Trial · NCT04144023

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

NCT04144023, Phase 1, Recruiting, Mayo Clinic

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ. Trials, record NCT04144023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04144023

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
NCT number
NCT04144023
Status
Recruiting
Phases
Phase 1
Enrollment
43 participants, estimated
Lead sponsor
Mayo Clinic
Conditions
Breast Ductal Carcinoma In Situ
Interventions
Granulocyte-Macrophage Colony-Stimulating Factor, Multi-epitope HER2 Peptide Vaccine H2NVAC, Therapeutic Conventional Surgery, Echocardiography Test, Biospecimen Collection, Biopsy Procedure
First posted
2019-10-30
Last updated
2026-03-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAdverse events2 yearsNumber of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
PrimaryDose limiting toxicities14 days post vaccination, 2 years
Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade \>= 3 allergic reaction, grade \>= 3 autoimmune reaction (except for autoimmune encephalitis grade \>=4), grade \>= 3 injection site reaction manifesting as an ulceration, grade \>= 3 neurologic problem, grade \>= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA015083Mayo Clinic Comprehensive Cancer Center Support GrantWILLMAN, CHERYL LYNNMAYO CLINIC ROCHESTERNATIONAL CANCER INSTITUTE1985 to 2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04144023

GET https://conductscience.org/api/trials/v1/NCT04144023/registered