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Recruiting NCT05325632

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

Phase II Interventional HER2-positive Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HER-2 pulsed DC1, Trastuzumab, Pertuzumab, Paclitaxel.
Who it may be relevant to
Registry conditions: HER2-positive Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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
  • Drug Pertuzumab
    840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.
  • Drug Paclitaxel
    80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18
  • Procedure Resection surgery
    After week 18, participants will undergo standard of care resection surgery.

Primary outcome measures

  • Lead in Phase: Immunogenicity of each dose level [Time frame: at 4 weeks]
  • Expansion Phase: Pathologic Complete Response Rate [Time frame: at 12 months]
Secondary outcome measures (4)
  • Expansion Phase: Radiologic tumor response rate after 6 weeks [Time frame: at 6 weeks]
  • Expansion Phase: Radiologic tumor response rate at completion of therapy [Time frame: at 12 months]
  • Expansion Phase: Immunogenicity [Time frame: at 12 months]
  • Recurrence Free Survival [Time frame: up to 5 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Moffitt Cancer Center — Tampa

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 PMID 39636623

Identifiers

NCT: NCT05325632 · MCC-20915

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗