A Phase I Safety and Immunogenicity Trial of MVA-BNŽ-HER2 Vaccine in HER-2-Positive Breast Cancer Patients Following Adjuvant Therapy
The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed dose of MVA-BNŽ-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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : MVA-BN-HER2
Phase: Phase 1
Ages Eligible For Study:
- 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-BNŽ-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-BNŽ-HER2). - ECOG Performance Score of 0, 1. - Predicted life expectancy ? 12 months - Left ventricular ejection fraction (LVEF) by ECHO ? LLN as defined by institutional standards - 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-BNŽ-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