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Study of HER2 Directed Dendritic Cell (DC1) Vaccine for HER2-positive Breast Cancer

This study is looking at whether adding an investigational vaccine called HER-2 pulsed DC1 to standard treatment can help people with HER2-positive breast cancer. You might be able to join if you have HER2-positive breast cancer that is at least 1 cm and are a candidate for standard neoadjuvant (given before main treatment) chemotherapy with Paclitaxel, Trastuzumab, and Pertuzumab. Participants will receive the vaccine, along with Trastuzumab, Pertuzumab, and Paclitaxel, followed by surgery. The study will measure how well the immune system responds to the vaccine and the rate of pathologic complete response (meaning no signs of cancer are found after treatment). The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 53 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive weekly vaccine doses for 6 weeks, with booster shots at months 6, 9, and 12. You would also receive Trastuzumab and Pertuzumab every three weeks, and weekly Paclitaxel for 12 weeks, followed by standard surgery.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the pathologic complete response rate at 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05325632

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~53 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:HER-2 pulsed DC1TrastuzumabPertuzumabPaclitaxelResection surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lead in Phase: Immunogenicity of each dose level
Measured over at 4 weeks
+1 more outcome measured

Conditions

HER2-positive Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Hyo (Heather) Han, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Neveen Abdo
[email protected]
813-745-4412
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Lead in Phase: Immunogenicity of each dose levelat 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.

  • Expansion Phase: Pathologic Complete Response Rateat 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)