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HER2-positive Breast CancerPhase 2NCT05325632

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

A Phase 2 study testing HER-2 pulsed DC1, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
HER-2 pulsed DC1, Trastuzumab and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
28 Oct 2021to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Neveen Abdo contact

813-745-4412

Neveen.Abdo@moffitt.org

United States1 site, 1 recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Hyo Han, MD

    Avan Armaghani, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
HER-2 pulsed DC1, Trastuzumab, Pertuzumab, Paclitaxel, Resection surgery
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • HER-2 pulsed DC1Biological

    Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

  • TrastuzumabDrug

    Also called Herceptin

    8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

  • PertuzumabDrug

    Also called Perjeta

    840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

  • PaclitaxelDrug

    Also called Abraxane

    80 mg/m^2 IV paclitaxel will be given weekly weeks 7-18

  • Resection surgeryProcedure or surgery

    After week 18, participants will undergo standard of care resection surgery.

Study groups in NCT05325632
Study groupRoleWhat they receive
Lead In - Dose level 1ExperimentalSix participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks
Receives: Biological: HER-2 pulsed DC1; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Procedure: Resection surgery
Lead In: Dose Level 2ExperimentalSix participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks
Receives: Biological: HER-2 pulsed DC1; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Procedure: Resection surgery
Expansion -Estrogen Receptor (ER) positiveExperimentalAn 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).
Receives: Biological: HER-2 pulsed DC1; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Procedure: Resection surgery
Expansion -Estrogen Receptor (ER) negativeExperimentalAn 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).
Receives: Biological: HER-2 pulsed DC1; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Procedure: Resection surgery

What is being measured

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

  1. Lead in Phase: Immunogenicity of each dose level

    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.

    Measured: at 4 weeks

  2. Expansion Phase: Pathologic Complete Response 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. 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)

    Measured: at 12 months

Secondary outcomes (4)

  1. Expansion Phase: Radiologic tumor response rate after 6 weeks

    Radiologic tumor response rate measured by MRI

    Measured: at 6 weeks

  2. Expansion Phase: Radiologic tumor response rate at completion of therapy

    Radiologic tumor response rate measured by MRI

    Measured: at 12 months

  3. Expansion Phase: Immunogenicity

    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.

    Measured: at 12 months

  4. Recurrence Free Survival

    Recurrence free survival defined as the length of time after treatment that patient survives without any signs or symptoms of cancer.

    Measured: up to 5 years

Timeline

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

  1. First posted13 Apr 2022
  2. Study start28 Oct 2021
  3. Primary completionFeb 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325632
Sponsor's protocol ID
MCC-20915
Status last verified
Feb 2026
First submitted
30 Mar 2022
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Han HS, Aldrich AL, Garg SK, Weinfurtner RJ, Nguyen JV, Mo Q, Whiting J, Childress J, Soliman H, Costa R, Armaghani A, Soyano A, Kiluk J, Hoover S, Lee MC, Khakpour N, Shenoi N, Jameel Z, Koski GK, Czerniecki BJ. Alteration of the Tumor Microenvironment With Intratumoral Dendritic Cells Before Chemotherapy in ERBB2 Breast Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Feb 1;11(2):119-127. doi: 10.1001/jamaoncol.2024.5371.

    PubMed 39636623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HER-2 pulsed DC1, Trastuzumab and Pertuzumab in people with HER2-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Mar 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Neveen Abdo (813-745-4412, Neveen.Abdo@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lead in Phase: Immunogenicity of each dose level (time frame: at 4 weeks). 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 NCT05325632, 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 2 Mar 2026.

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