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Studies

Interventional Recruiting Phase 2

NCT05325632 on ClinicalTrials.gov

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

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

  • Sponsor: Moffitt Cancer Center
  • Collaborators: ImmunoRestoration
  • Enrollment: 53 (Estimated)
  • Study start: 2021-10-28 (Actual)
  • Primary completion: 2027-02-01 (Estimated)
  • Study completion: 2027-09-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Sequential
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • HER2-positive Breast Cancer

Intervention / Treatment

  • Biological: HER-2 pulsed DC1
  • Drug: Trastuzumab
  • Drug: Pertuzumab
  • Drug: Paclitaxel
  • Procedure: Resection surgery

Primary Outcome Measures

  • Lead in Phase: Immunogenicity of each dose level (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.
  • Expansion Phase: Pathologic Complete Response Rate (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)

Countries

United States

Locations and Investigators

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

Study Officials