Phase II clinical trial of personalized peptide vaccination for advanced breast cancer

UMIN ID: UMIN000001844

Registered date:05/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): (1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide). Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 45: Final evaluation. The 1st treatment (total 6 times, every weeks) is finished

Outcome(s)

• Primary Outcome: Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
• Secondary Outcome: 1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The following patients must be excluded 1. Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2. Patients with the past history of severe allergic reactions. 3. Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4. Patients who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Kurume University Cancer Vaccine Center
• Source(s) of Monetary Support: None