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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-08

Study Completion Date

2024-02-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HER-2 Pulsed Dendritic Cell Vaccine

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.

Group Type EXPERIMENTAL

HER-2 pulsed Dendritic Cell Vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No