Clinical Trial 19117

Cancer Type:
Interventions:

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Heather Han

Overview

Study Title

A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients with HER-2 Positive Breast Cancer

Summary

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Objective

Inclusion Criteria

  • Clinical stage I-III breast cancer with any invasive residual disease in the breast or axillary nodes following neoadjuvant chemotherapy including HER-2 directed treatment.
  • Patients who have received a total of at least 36 weeks of trastuzumab therapy (including neoadjuvant and adjuvant settings).
  • Less than 6 months from the completion of last trastuzumab infusion.
  • Age ≥ 18 years.
  • Eastern Cooperative Group (ECOG) performance status 0 or 1.
  • Must have normal organ and marrow function as defined in the study protocol within 2 weeks of registration.
  • Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration).
  • Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose.
  • Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures.

  • Exclusion Criteria

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncontrolled autoimmune disease requiring active systemic treatment.
  • Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
  • Pregnant or breast feeding.
  • Known HIV-positive.
  • Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
  • Major surgery within 4 weeks of initiation of study drug.
  • Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded.
  • Potential participant is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.