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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00485277

Run by

Bavarian Nordic

People needed

9

Starts

2007-06-01

Expected to finish

2010-09-01

Last updated by the study team

2019-03-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alta Bates Herrick Hospital Comprehensive Cancer Center — Berkeley, California, United States
• Stanford Cancer Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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