Breast CancerEarly Phase 1NCT03387553

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

A Early Phase 1 study testing Dendritic Cell Vaccine (DC1), Neoadjuvant Chemotherapy and Curative Surgery in people with Breast Cancer and Breast Cancer Female, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Breast Cancer Female, Breast Cancer, Male
What is being tested?: Dendritic Cell Vaccine (DC1), Neoadjuvant Chemotherapy and Curative Surgery
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 6 Jun 2018to 19 Feb 2026
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have histologically confirmed clinical stage II or III ERPR- HER2+ (per CAP criteria) invasive carcinoma of the breast
Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status less than 2
Patients must have normal organ and marrow function as defined below:
leukocytes ≥3,000/μL

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absolute neutrophil count ≥1,500/μL
platelets ≥100,000/μL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
creatinine within normal institutional limits - OR -
creatinine clearance ≥60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Cardiac ejection fraction within institutional normal limits by either MUGA or ECHO 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.

Who cannot join

Patients 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
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 (docetaxel, carboplatin, trastuzumab, pertuzumab)
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.
Women who are pregnant or breastfeeding
Known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).
Pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents

Trial locations and contacts

1 site in 1 country.

United States1 site

H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Pilot Study Utilizing a HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+ Breast Cancer

The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.

Read the detailed description

The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming study vaccination schedules.

Arm A: One DC1 study vaccination per week x 3 weeks. Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.

Following accrual of this initial group of 12 participants, HER2 ELISPOT post study vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.

Second phase of accrual will consist of 14 additional participants to undergo study vaccination using the optimal schedule declared in the first phase of the trial. The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming study vaccination schedules.

Arm A: One DC1 study vaccination per week x 3 weeks Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.

Second phase of accrual will consist of 14 additional participants to undergo study vaccination using the optimal schedule declared in the first phase of the trial.

Conditions: Breast Cancer, Breast Cancer Female, Breast Cancer, Male, Invasive Breast Cancer, HER2-positive Breast Cancer, HER2 Positive Breast Carcinoma
Being tested: Dendritic Cell Vaccine (DC1), Neoadjuvant Chemotherapy, Curative Surgery
Keywords: Immunotherapy, Dendritic Cell Vaccine, DC1
Medical subject headings: Breast Neoplasms, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dendritic Cell Vaccine (DC1)Biological
Also called Immunotherapy
Study Vaccine:
Lead In Phase - Weekly as outlined in each treatment Arm.
Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.
Neoadjuvant ChemotherapyDrug
Also called TCHP
Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
Curative SurgeryProcedure or surgery
Planned definitive curative surgery at 26 to 28 weeks.

Study groups in NCT03387553
Study group	Role	What they receive
Lead In Phase - Arm A	Active comparator	Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks. Receives: Biological: Dendritic Cell Vaccine (DC1); Drug: Neoadjuvant Chemotherapy; Procedure: Curative Surgery
Lead In Phase - Arm B	Active comparator	Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks. Receives: Biological: Dendritic Cell Vaccine (DC1); Drug: Neoadjuvant Chemotherapy; Procedure: Curative Surgery
Expansion Phase	Experimental	DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians). Receives: Biological: Dendritic Cell Vaccine (DC1); Drug: Neoadjuvant Chemotherapy; Procedure: Curative Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Expansion Phase Schedule Selection by Week 4
Immunogenicity of HER2 DC Vaccine per treatment Arm, based on week 4 ELISPOTs. Three metrics of CD4+ Th1 response will be computed for each patient, (a) overall anti-HER2 responsivity (i.e., if patient demonstrates a positive ELISPOT response to >1 peptide, (b) response repertoire (i.e., number of reactive peptides) and (c) cumulative response (total SFC/10^6 cells across 6 peptides). The primary immunogenicity outcome will be the cumulative response at week 4 (week after completion of all vaccinations).
Measured: By Week 4
Pathologic Complete Response (pCR) Rate
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.The definition of pathologic complete response (pCR) will be ypT0/is N0 (no residual viable invasive disease in the breast or nodes). Any response less than pCR will be scored as incomplete response or progression (if tumor size increases during neoadjuvant chemotherapy on physical exam/breast imaging).
Measured: Week 26 to 28 - At post-surgical pathological assessment

Secondary outcomes (1)

Recurrence Free Survival (RFS)
Recurrence-free survival (RFS) will be defined as the time from first vaccination to documented recurrence (any breast event), death due to any cause or last patient contact that documents recurrence-free status (i.e., a clinic or scan date).
Measured: Up to 3 years post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 201819 Feb 2026

First posted2 Jan 2018
Study start6 Jun 2018
Primary completion29 Aug 2023
Study completion19 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming vaccination schedules. Following accrual of this initial group of 12 patients, HER2 ELISPOT post vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03387553
Sponsor's protocol ID: MCC-19337
Status last verified: Sep 2026
First submitted: 19 Dec 2017
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Soliman H, Aldrich A, Abdo N, Han H, Soyano A, Costa R, Armaghani A, Kiluk J, Khakpour N, Lee MC, Hoover S, Laronga C, Niell B, Mooney B, Weinfurtner RJ, Rosa M, Czerniecki B. A pilot study incorporating HER2-directed dendritic cells into neoadjuvant therapy of early stage HER2+ER- breast cancer. NPJ Breast Cancer. 2025 Mar 17;11(1):29. doi: 10.1038/s41523-025-00742-x.
PubMed 40097486

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Utilizing a HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+ Breast Cancer
ClinicalTrials.gov ID: NCT03387553
Acronym / sponsor ID: MCC-19337
Conditions: Breast Cancer, Breast Cancer Female, Breast Cancer, Male, Invasive Breast Cancer, HER2-positive Breast Cancer, HER2 Positive Breast Carcinoma
Keywords: Immunotherapy, Dendritic Cell Vaccine, DC1
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 6 Jun 2018 (actual)
Primary completion: 29 Aug 2023 (actual)
Study completion: 19 Feb 2026 (actual)
First posted: 2 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Arm A: One DC1 study vaccination per week x 3 weeks. Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.

Arm A: One DC1 study vaccination per week x 3 weeks Arm B: Two DC1 study vaccinations per week (given 3 days apart for example Mon and Thurs or Tues and Friday) x 3 weeks.

Second phase of accrual will consist of 14 additional participants to undergo study vaccination using the optimal schedule declared in the first phase of the trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming vaccination schedules. Following accrual of this initial group of 12 patients, HER2 ELISPOT post vaccination responses will be assessed to determine which of the two sequences provides the greater increase in anti HER2 response at week 4 over baseline. This will determine which sequence will be used in the second expansion phase of accrual. If both arms are determined equal then Arm A will be selected as the default sequence.

Arm	Type	Receives
Lead In Phase - Arm A	Active comparator	Biological: Dendritic Cell Vaccine (DC1), Drug: Neoadjuvant Chemotherapy, Procedure: Curative SurgeryArm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.
Lead In Phase - Arm B	Active comparator	Biological: Dendritic Cell Vaccine (DC1), Drug: Neoadjuvant Chemotherapy, Procedure: Curative SurgeryArm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.
Expansion Phase	Experimental	Biological: Dendritic Cell Vaccine (DC1), Drug: Neoadjuvant Chemotherapy, Procedure: Curative SurgeryDC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Participants must have histologically confirmed clinical stage II or III ERPR- HER2+ (per CAP criteria) invasive carcinoma of the breast
Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status less than 2
Patients must have normal organ and marrow function as defined below:

Key exclusion criteria (8 listed)

Patients 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
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 (docetaxel, carboplatin, trastuzumab, pertuzumab)
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dendritic Cell Vaccine (DC1)Also: ImmunotherapyStudy Vaccine: Lead In Phase - Weekly as outlined in each treatment Arm. Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase. Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery. Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months.	Biological	Expansion Phase, Lead In Phase - Arm A, Lead In Phase - Arm B
Neoadjuvant ChemotherapyAlso: TCHPUpon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.	Drug	Expansion Phase, Lead In Phase - Arm A, Lead In Phase - Arm B
Curative SurgeryPlanned definitive curative surgery at 26 to 28 weeks.	Procedure or surgery	Expansion Phase, Lead In Phase - Arm A, Lead In Phase - Arm B

Primary outcome

Expansion Phase Schedule Selection by Week 4
Time frame: By Week 4
Immunogenicity of HER2 DC Vaccine per treatment Arm, based on week 4 ELISPOTs. Three metrics of CD4+ Th1 response will be computed for each patient, (a) overall anti-HER2 responsivity (i.e., if patient demonstrates a positive ELISPOT response to >1 peptide, (b) response repertoire (i.e., number of reactive peptides) and (c) cumulative response (total SFC/10^6 cells across 6 peptides). The primary immunogenicity outcome will be the cumulative response at week 4 (week after completion of all vaccinations).
Pathologic Complete Response (pCR) Rate
Time frame: Week 26 to 28 - At post-surgical pathological assessment
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.The definition of pathologic complete response (pCR) will be ypT0/is N0 (no residual viable invasive disease in the breast or nodes). Any response less than pCR will be scored as incomplete response or progression (if tumor size increases during neoadjuvant chemotherapy on physical exam/breast imaging).

1 secondary outcome

Recurrence Free Survival (RFS)
Time frame: Up to 3 years post-surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Derived from this study: PubMed 40097486Soliman H, Aldrich A, Abdo N, Han H, Soyano A, Costa R, Armaghani A, Kiluk J, Khakpour N, Lee MC, Hoover S, Laronga C, Niell B, Mooney B, Weinfurtner RJ, Rosa M, Czerniecki B. A pilot study incorporating HER2-directed dendritic cells into neoadjuvant therapy of early stage HER2+ER- breast cancer. NPJ Breast Cancer. 2025 Mar 17;11(1):29. doi: 10.1038/s41523-025-00742-x.
Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haten Soliman, M.D. principal investigator

H. Lee Moffitt Cancer Center and Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expansion Phase Schedule Selection by Week 4 (time frame: By Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03387553, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.