A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Breast Cancer After Adjuvant Therapy

Not Recruiting

Trial ID: NCT01152398


The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast cancer. The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune response, which is intended to target HER-2-expressing tumor cells, and may induce tumor regression or slow progression of disease.

Official Title

A Phase I Safety and Immunogenicity Trial of MVA-BN®-HER2 Vaccine in HER-2-Positive Breast Cancer Patients Following Adjuvant Therapy

Stanford Investigator(s)

Allison W. Kurian, M.D., M.Sc.
Allison W. Kurian, M.D., M.Sc.

Professor of Medicine (Oncology) and of Epidemiology and Population Health

Frank E. Stockdale
Frank E. Stockdale

Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus


Inclusion Criteria:

   - Signed Informed Consent

   - Women, ≥ 18 years of age

   - Histologically documented, HER-2-positive breast cancer without metastatic disease.
   Hormone receptor (ER/PR) status may be either positive or negative. HER-2 (+) status
   may be determined by one of the following measurements:

   - Immunohistochemistry 3+ or FISH/CISH+ (HER-2 gene signal to centromere 17 signal > 2).
   NOTE: HER-2 assessment may have been on initial diagnosis and need not be repeated.

   - Patients should be assessed as having no evidence of disease (NED) at the end of
   adjuvant chemotherapy. In addition, these patients must have a clinical evaluation and
   lab work as standard of care disease assessment without evidence of recurrence within
   28 days of the first planned dose of MVA-BN®-HER2.

   - Completed adjuvant and/or neoadjuvant chemotherapy for breast cancer at least 3 months
   previously (measured from the date of the last dose of chemotherapy) and prior to the
   first planned dose of MVA-BN®-HER2).

   - ECOG Performance Score of 0, 1.

   - Predicted life expectancy ≥ 12 months

   - Left ventricular ejection fraction (LVEF) by ECHO ≥ LLN as defined by institutional

   - Women of childbearing potential must:

      - have a negative serum or urine pregnancy test, and

      - must agree to use a medically acceptable barrier and/or chemical method of
      contraception throughout the study treatment period and for 28 days after the
      last dose of MVA-BN®-HER2.

   - No significant cardiac, bone marrow dysfunction, or coagulopathy (defined as no Grade
   3 or greater AE according to NCI CTCAE v 3.0). No significant hepatic or renal
   dysfunction (defined as no Grade 2 or greater AE according to NCI CTCAE v 3.0.
   Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may
   be eligible for inclusion provided an exemption is granted by the study Medical
   Monitor prior to enrollment.

   - A negative virology screen for HIV, HBsAg, and HCV

Exclusion Criteria:

   - Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular
   disease such as stroke or myocardial infarction (current or within the past 6 months)

   - History of cardiac toxicity secondary to chemotherapy or Herceptin immunotherapy (LVEF
   decline of 15% or greater from baseline)

   - History of prior malignancies other than breast cancer within the past 5 years,
   excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the

   - Any breast cancer metastases beyond the lymph nodes

   - Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin
   or tobramycin

   - Chronic administration (defined as 6 or more consecutive days of use) of systemic
   corticosteroids within 14 days of the first planned dose of MVA-BN®-HER2. Limited use
   of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas
   is allowed.

   - History of or active autoimmune disease. Persons with vitiligo or thyroid disease
   taking thyroid replacement hormones are not excluded.

   - Prior solid organ or hematopoietic allogenic transplant(s)

   - Prior use of hematopoietic growth factors (e.g., GM-CSF) within 14 days of the first
   planned dose of MVA-BN®-HER2

   - Receipt of an investigational agent within 28 days of the first planned dose of

   - Prior "vaccine" therapy for breast cancer at any time

   - Vaccination:

Live (attenuated) vaccine (e.g., FluMist®) Vaccination with a live vaccine within 28 days
of the first planned dose of MVA-BN®-HER2, or plans to receive a live vaccine within 28
days after the last dose of MVA-BN®-HER2 is not allowed Killed (inactivated) vaccine
(e.g.,PneumoVax®) Vaccination with a killed vaccine within 14 days of the first planned
dose of MVA-BN®-HER2, or plans to receive a killed vaccine within 14 ' days after the last
dose of MVA-BN®-HER2 is not allowed

   - A maximum cumulative dose of prior doxorubicin > 360 mg/m2 or epirubicn > 720 mg/m2

   - Radiation therapy within 14 days of the first planned dose of MVA-BN®-HER2 or plans
   for radiation therapy after enrollment. Prior to initiating palliative radiation
   during the treatment phase of the study, the Sponsor's medical monitor or designee
   must be contacted.

   - Pregnant, lactating, or nursing

   - Any condition which, in the opinion of the investigator, would prevent full
   participation in this trial or the long-term follow-up study, or would interfere with
   the evaluation of the trial endpoints


biological: MVA-BN-HER2

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Chen

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