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

Inclusion Criteria:

Signed Informed Consent
Women, ≥ 18 years of age
Histologically documented, HER-2 (+) breast cancer with metastatic disease.
Evaluable or measurable disease. PATIENTS MAY BE NED. Patients must be assessed as having stable disease or better at the end of 1st- or 2nd-line chemotherapy. In addition, patients must have a tumor assessment within 28 days of the first planned dose of MVA-BN®-HER2, and have a response status of SD or better.
Prior chemotherapy for metastatic breast cancer
Completed 1st- or 2nd-line chemo for mBrCA at least 3 weeks (from the date of the last dose) prior to the first dose of MVA-BN®-HER2
ECOG Performance Score of 0, 1, or 2
Life expectancy ≥ 6 months
Left ventricular ejection fraction (LVEF) by ECHO or MUGA ≥ LLN
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. No significant hepatic or renal dysfunction.
A negative virology screen for HIV, hepatitis B surface antigen, hepatitis C, and HTLV-1

Exclusion Criteria:

Patients may not have:

Known history of metastasis to the central nervous system
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 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 cervix
Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
Chronic administration (5 or more consecutive days) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-HER2.
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 28 days of the first planned dose of MVA-BN®-HER2
Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN®-HER2
Prior "vaccine" therapy for breast cancer at any time
Vaccination: Vaccinations with a live (attenuated) vaccine within 28 days of the first or last dose of study drug; or vaccinations with a killed (inactivated) vaccine within 14 days of the first or last dose of study drug.
A maximum cumulative dose of prior doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2
Radiation therapy within 28 days of the first planned dose of MVA-BN®-HER2 or plans for radiation therapy after enrollment.
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