clinical trial of CHP-HER2 cancer vaccine with immuno-adjuvant, OK-432, for advanced breast cancer
Phase 1
- Conditions
- Resected locally-advanced breast cancer
- Registration Number
- JPRN-UMIN000001286
- Lead Sponsor
- Mie University, University of Ocupational and Environmental Health, Nagasaki University, National Hospital Organization Saga National Hospital, Hamamatsu Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HER2-specific immune responses
- Secondary Outcome Measures
Name Time Method Time to reccurence Adverse events