Resected locally-advanced breast cancer
Conditions
Interventions
CHP-HER2 300microgram, OK-432 0.2KE, subcutaneous injection, q2wks x12 doses, followed by booting doses with three-month interval.
Sponsors
Mie University, University of Ocupational and Environmental Health, Nagasaki University, National Hospital Organization Saga National Hospital, Hamamatsu Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Clinical stage IIIA or IIIB(UICC-TNM classification) histoligically confirmed primary breast cancer, which expresses 2+ or 3+ HER2, scored by HercepTest. Negative both for estrogen and progesteron receptors. Lating 4 to 12 weeks from surgery, chemotherapy, and radiotherapy, and confirmed as disease-free. One year or less lating from tumor resection. Performance status(ECOG) 0 or 1. Neutrophil counts 1,500/uL or more. Lymphocytes 500/uL or more. Platelets 100,000/uL or more. Hemoglobin 9.0 g/dl or more. Serum creatinine 1.8 mg/dl or less. Serum bilirubin 2.0mg/dl or less. AST(GOT)/ALT(GPT) both 100 IU/L or less. Having written informed consent.
Exclusion criteria
Exclusion criteria: Previous uses of trastuzumab(Herceptin). Uncontrolled heart failure. Impaired cardiac function, 50% or less of ejection fraction. Uncontrolled arrythmia. Uncontrolled hypertention. Angina pectoris, cardiac valvular disease. Pulmonary fibrosis. Uncontrolled diabetes mellitus. Antibody-requiring active infection. Blood clotting disorder. Positive for HBV, HIV or HTLV-1, except HBV healthy carrier and negatives for HCVmRNA. History of penicillin allergy. Ongoing corticosteroid therapy. Pregnancy Willing to be pregnant. Inappropriate for study entry judged by an attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HER2-specific immune responses | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reccurence Adverse events | — |
Countries
Japan
Contacts
Public ContactShinichi Kageyama
Mie University Graduate School of Medicine Department of Cancer Vaccine/Immuno-Gene Therapy
Outcome results
None listed