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A Phase I Safety and Immunogenicity Trial of MVA-BN®-HER2 Vaccine in Locally Advanced and Advanced HER2+ Breast Cancer (GENE TRANSFER PROTOCOL)

Phase 1
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase I Safety and Immunogenicity Trial of MVA-BN®-HER2 Vaccine in Locally Advanced and Advanced HER2+ Breast Cancer (GENE TRANSFER PROTOCOL)

Inclusion Criteria

- Patients are women 18 years of age or older with histologically confirmed
HER-2-positive breast cancer by IHC (3+) or CISH/FISH.

- Patients must have acceptable performance status, life expectancy, and general health
excluding breast cancer.

- Patients cannot be pregnant, lactating, or breast feeding. Patients must have LVEF by

- Patients must have no significant cardiac, bone marrow dysfunction, or coagulopathy
(defined as no Grade 3 or greater AE according to NCI CTCAE v 3.0) or significant
hepatic or renal dysfunction (defined as no Grade 2 or greater AE according to NCI
CTCAE v 3.0).

- Stage III patients must have completed surgery and adjuvant or neoadjuvant
chemotherapy and must have been off Trastuzumab for at least 3 months.

- Stage IV patients must have stable disease without evidence of disease progression
and must not be receiving chemotherapy.

- Concomitant therapy discussed in this section refers only to the treatment phase of
the study:

- Concomitant use of previously prescribed endocrine therapy is accepted for either
stage III or IV patients.

- Stage IV patients only, may be receiving concomitant Her-2 targeted therapies on
study (Trastuzumab and/or lapatinib).

- Bisphosphonates: Concomitant use of previously prescribed bisphosphonates is allowed.

- Concomitant Her-2 targeted therapy (Trastuzumab and lapatinib) is allowed for the
stage IV treatment group.

- Use of Her2- targeted therapy, chemotherapy, corticosteroids, and other agents for
the treatment of HER-2 (+) breast cancer during the long-term follow-up phase of the
study is at the discretion of the investigator.

- Patients with history of cardiovascular disease, prior malignancies, or prior breast
cancer 'vaccines', are excluded from this trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of MVA-BN®-HER2

Outcome Time Frame:

as assessed by the incidence of AEs, changes in ECOG performance status, ECGs, LVEF measurements (ECHO or MUGA scans), and lab tests.

Safety Issue:


Principal Investigator

Dr. Ellie Guardino MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer Metastatic Breast Cancer
  • Breast Neoplasms



Stanford University School of MedicineStanford, California  94305-5317