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HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy (Neoadjuvant)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02061423
First received: February 10, 2014
Last updated: November 30, 2016
Last verified: November 2016

February 10, 2014
November 30, 2016
January 2014
January 2018   (final data collection date for primary outcome measure)
  • Participation Compliance [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]
    Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (6 weekly vaccinations). Data collection will include rate of successful completion and occurrence rate for each reason stated for non-completion.
  • Occurrence of Treatment Related Adverse Events [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]
    Number of participants with treatment related adverse events, per event category.
  • Blood Pressure [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Blood pressure will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.
  • Temperature [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Temperature will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.
  • Pulse [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Pulse will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.
Complete list of historical versions of study NCT02061423 on ClinicalTrials.gov Archive Site
  • Immunogenicity [ Time Frame: Up to 5 years follow-up ] [ Designated as safety issue: No ]
    Immunogenicity will be evaluated by descriptive statistics, plots of pre- and post-treatment values and fold changes. Immune response rate and 95% exact confidence interval will be calculated.
  • Anti-HER2 Immunity [ Time Frame: Up to 5 years follow-up ] [ Designated as safety issue: No ]
    Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.
  • Immune Response [ Time Frame: 6-8 weeks, 1 year ] [ Designated as safety issue: No ]
    Subjects will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing.
  • Mammogram [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    All subjects will have a post-vaccine bilateral mammogram to evaluate response to vaccination. Mammograms will be performed within two weeks after the 6th vaccination.
Not Provided
Not Provided
 
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy
The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
Biological: HER-2 pulsed Dendritic Cell Vaccine
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.
Experimental: HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.
Intervention: Biological: HER-2 pulsed Dendritic Cell Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2018
January 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ≥ 18 years.
  • HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
  • Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
  • Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
  • Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria:

  • Pregnant or lactating.
  • Positive for HIV or hepatitis C at baseline by self report.
  • Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
  • Potential participants with MUGA < 50% EF.
  • Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Female
18 Years and older   (Adult, Senior)
No
United States
 
NCT02061423
MCC-18776, UPCC26113
No
Not Provided
Not Provided
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Not Provided
Principal Investigator: Brian Czerniecki, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP