NCT02063724

Brief Summary

The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 6, 2014

Results QC Date

August 30, 2018

Last Update Submit

February 5, 2026

Conditions

Breast Cancer

Keywords

Invasive Breast CancerBreast CancerImmunotherapyVaccineDendritic Cell

Outcome Measures

Primary Outcomes (1)

  • Rate of Treatment Regimen Completion

    Number of participants willing and able to complete treatment regimen, to address feasibility.

    12 months

Secondary Outcomes (2)

  • Immune Response

    12 months

  • Occurrence of Treatment Related Adverse Events

    2 years

Study Arms (1)

HER-2 Pulsed Dendritic Cell Vaccine

EXPERIMENTAL

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.

Biological: HER-2 pulsed Dendritic Cell Vaccine

Interventions

HER-2 pulsed Dendritic Cell VaccineBIOLOGICAL

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10\^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.

HER-2 Pulsed Dendritic Cell Vaccine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over Age 18 years.
  • Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (\>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
  • Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
  • Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
  • Willing to use birth control if necessary.
  • Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

You may not qualify if:

  • Pregnant or lactating.
  • Positive for positive HIV or hepatitis C at baseline.
  • Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
  • Major cardiac illness MUGA less than 50% EF.
  • Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (4)

  • Czerniecki BJ, Roses RE, Koski GK. Development of vaccines for high-risk ductal carcinoma in situ of the breast. Cancer Res. 2007 Jul 15;67(14):6531-4. doi: 10.1158/0008-5472.CAN-07-0878.

    PMID: 17638860BACKGROUND

  • Czerniecki BJ, Koski GK, Koldovsky U, Xu S, Cohen PA, Mick R, Nisenbaum H, Pasha T, Xu M, Fox KR, Weinstein S, Orel SG, Vonderheide R, Coukos G, DeMichele A, Araujo L, Spitz FR, Rosen M, Levine BL, June C, Zhang PJ. Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Cancer Res. 2007 Feb 15;67(4):1842-52. doi: 10.1158/0008-5472.CAN-06-4038. Epub 2007 Feb 9.

    PMID: 17293384BACKGROUND

  • Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki BJ. A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. J Immunother. 2012 Jan;35(1):54-65. doi: 10.1097/CJI.0b013e318235f512.

    PMID: 22130160BACKGROUND

  • Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki BJ. HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ. Cancer. 2012 Sep 1;118(17):4354-62. doi: 10.1002/cncr.26734. Epub 2012 Jan 17.

    PMID: 22252842BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Brian Czerniecki
Organization
H. Lee Moffitt Cancer Center and Research Institute
brian.czerniecki@moffitt.org
813-745-7575

Study Officials

  • Brian Czerniecki, M.D., Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 14, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2022

Last Updated

February 20, 2026

Results First Posted

February 15, 2019

Record last verified: 2026-02

Locations

US(1)