Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

February 26, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer

The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor receptor 2) positive breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Martine Extermann, MD, PhD
        • Sub-Investigator:
          • Brian Czerniecki, MD, PhD
        • Sub-Investigator:
          • Hatem Soliman, MD
        • Sub-Investigator:
          • Avan Armaghani, MD
        • Sub-Investigator:
          • Ricardo Costa, MD, MSc
        • Sub-Investigator:
          • Hung Khong, MD
        • Sub-Investigator:
          • Kimberley Lee, MD, MHS
        • Sub-Investigator:
          • Loretta Loftus, MD, MBA
        • Sub-Investigator:
          • Aixa Soyano Muller, MD
        • Principal Investigator:
          • Hyo Han, MD
        • Sub-Investigator:
          • Christine Sam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests
  • Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Participants must have normal organ and marrow function as defined per protocol.
  • Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram at baseline.
  • Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed.
  • Patients may not be receiving any other investigational agents for the treatment of their breast cancer.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (paclitaxel, trastuzumab, pertuzumab).
  • Participants who are unwilling or unable to undergo an apheresis for production of their vaccine.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women and women who are breastfeeding.
  • Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lead In - Dose level 1
Six participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks
Biological: HER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
Drug: Trastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
Other Names:
  • Herceptin
Drug: Pertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Other Names:
  • Perjeta
Drug: Paclitaxel
80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18
Other Names:
  • Abraxane
Procedure: Resection surgery
After week 18, participants will undergo standard of care resection surgery.
Experimental: Lead In: Dose Level 2
Six participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks
Biological: HER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
Drug: Trastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
Other Names:
  • Herceptin
Drug: Pertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Other Names:
  • Perjeta
Drug: Paclitaxel
80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18
Other Names:
  • Abraxane
Procedure: Resection surgery
After week 18, participants will undergo standard of care resection surgery.
Experimental: Expansion -Estrogen Receptor (ER) positive
An additional 24 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).
Biological: HER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
Drug: Trastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
Other Names:
  • Herceptin
Drug: Pertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Other Names:
  • Perjeta
Drug: Paclitaxel
80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18
Other Names:
  • Abraxane
Procedure: Resection surgery
After week 18, participants will undergo standard of care resection surgery.
Experimental: Expansion -Estrogen Receptor (ER) negative
An additional 23 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).
Biological: HER-2 pulsed DC1
Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.
Drug: Trastuzumab
8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks
Other Names:
  • Herceptin
Drug: Pertuzumab
840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
Other Names:
  • Perjeta
Drug: Paclitaxel
80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18
Other Names:
  • Abraxane
Procedure: Resection surgery
After week 18, participants will undergo standard of care resection surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lead in Phase: Immunogenicity of each dose level
Time Frame: at 4 weeks
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
at 4 weeks
Expansion Phase: Pathologic Complete Response Rate
Time Frame: at 12 months
Pathologic complete response rate of participants treated in the Expansion Phase. Clinical efficacy will be defined by the pathologic complete response (pCR) rate, the percentage of patients who achieve pCR based on surgical pathology assessment. Pathologic Complete Response defined as no residual invasive disease in the breast and nodes (ypT0/is N0) at definitive surgery after completion of protocol therapy. The pathologic response to treatment will be assessed by the pathologist. The "Residual Cancer Burden" (RCB) for each patient as described in the online calculator also will be evaluated per the pathologist. (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3)
at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expansion Phase: Radiologic tumor response rate after 6 weeks
Time Frame: at 6 weeks
Radiologic tumor response rate measured by MRI
at 6 weeks
Expansion Phase: Radiologic tumor response rate at completion of therapy
Time Frame: at 12 months
Radiologic tumor response rate measured by MRI
at 12 months
Expansion Phase: Immunogenicity
Time Frame: at 12 months
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
at 12 months
Recurrence Free Survival
Time Frame: up to 5 years
Recurrence free survival defined as the length of time after treatment that patient survives without any signs or symptoms of cancer.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ImmunoRestoration

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hyo (Heather) Han, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-20915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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