clinical trial of CHP-HER2 cancer vaccine with immuno-adjuvant, OK-432, for advanced breast cancer

UMIN ID: UMIN000001286

Registered date:02/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Resected locally-advanced breast cancer
• Date of first enrollment: 2006/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CHP-HER2 300microgram, OK-432 0.2KE, subcutaneous injection, q2wks x12 doses, followed by booting doses with three-month interval.

Outcome(s)

• Primary Outcome: HER2-specific immune responses
• Secondary Outcome: Time to reccurence Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: Mie University, University of Ocupational and Environmental Health, Nagasaki University, National Hospital Organization Saga National Hospital, Hamamatsu Medical Center
• Source(s) of Monetary Support: Cancer Translational Research, Ministry of Education, Culture, Sports, Science and Technology, and othrs