Clinical Trial 18776

Cancer Type: Breast
Interventions:HER-2 Pulsed-DC Vaccine

Study Type: Treatment
Phase of Study: Phase I
Investigators:


    Overview

    Study Title

    Multisite Pilot Phase I HER-2 Pulsed-DC Vaccine to Prevent Recurrence for Patients with HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy

    Summary

    The main goals of the study are: 1. To determine safety of the study vaccine; 2. To determine whether the study vaccine can provoke an immune response; 3. To determine whether circulating tumor cells can be used to assess response to vaccination.

    Objective

    The primary objectives are to determine feasibility and safety. The secondary objectives are to evaluate immunogenicity and anti-HER2 immunity.

    Inclusion Criteria

  • Women >= 18 years.
  • Potential participants with HER-2 expressing stage I ¿ III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
  • Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
  • Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
  • Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

  • Exclusion Criteria

  • Pregnant or lactating females.
  • Positive for HIV or hepatitis C at baseline by self report.
  • Coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
  • Multigated acquisition scan (MUGA) results less than 50% EF.
  • Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).