Clinical Trials /

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

NCT02061423

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02061423

Trial Eligibility

Document

Title

  • Brief Title: HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MCC-18776
  • SECONDARY ID: UPCC26113
  • NCT ID: NCT02061423
  • NCT ALIAS: NCT02110199

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
HER-2 pulsed Dendritic Cell VaccineHER-2 Pulsed Dendritic Cell Vaccine

Purpose

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.

Detailed Description

      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.

Trial Arms

NameTypeDescriptionInterventions
HER-2 Pulsed Dendritic Cell VaccineExperimental6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.
  • HER-2 pulsed Dendritic Cell Vaccine

Eligibility Criteria

        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).
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Participation Compliance
Time Frame:Up to 18 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Immunogenicity
Time Frame:Up to 5 years follow-up
Safety Issue:
Description: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.
Measure:Anti-HER2 Immunity
Time Frame:Up to 5 years follow-up
Safety Issue:
Description:Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Invasive Breast Cancer
  • Breast Cancer
  • Immunotherapy
  • Vaccine
  • Dendritic Cell
  • Neoadjuvant

Last Updated

May 24, 2021