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A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer
Trial ID: NCT00485277
The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in patients with Her-2-positive metastatic breast cancer. The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell, that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow progression of disease.
A Phase I Trial of a Fixed Dose of MVA-BN-HER2 Following 1st- or 2nd-Line Chemotherapy for HER-2-Positive Metastatic Breast Cancer
- 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
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
- Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin
- 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
- 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
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