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

Phase 1CompletedNCT02061423

H. Lee Moffitt Cancer Center and Research Institute7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

HER-2 pulsed Dendritic Cell VaccineBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Participation Compliance

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.

Time frame: Up to 18 months

Occurrence of Treatment Related Adverse Events

Number of participants with treatment related adverse events, per event category.

Time frame: Up to 18 months

Secondary Outcomes

Immunogenicity

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.

Time frame: Up to 5 years follow-up

Anti-HER2 Immunity

Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.

Time frame: Up to 5 years follow-up

Data from ClinicalTrials.gov

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