Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
- Conditions
- Neoplasms, Breast
- Interventions
- Biological: GSK Biologicals' 719125
- Registration Number
- NCT00140738
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.
- Detailed Description
This Phase I/II study will be conducted according to a multicenter, open-label design. At least 20 patients will receive the vaccine as first-line and at least 20 as second-line treatment. The treatment will comprise a maximum of 18 injections of dHER2 vaccine. Follow-up phase: This will commence with the end-of-treatment examination, followed by examinations three months, six months and twelve months after the last study vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group B GSK Biologicals' 719125 Patients receive study vaccinations as second-line therapy Group A GSK Biologicals' 719125 Patients receive study vaccinations in 3 consecutive cycles: * In Cycle 1 each patients will receive six vaccinations at two-week intervals followed by evaluation. * In Cycle 2, subjects will patients six vaccinations at two-week intervals followed by evaluation. * In Cycle 3, subjects will patients six vaccinations at three-week intervals.
- Primary Outcome Measures
Name Time Method Vaccine-related Grade 3 or 4 toxicity (other than skin toxicity and influenza-like symptoms) according to the Common Terminology Criteria for Adverse Events version 3.0 During the study. Objective clinical response (CR or PR) At each tumor evaluation (Visits 7, 14 and 21)
- Secondary Outcome Measures
Name Time Method Time to onset of response, defined as time from first vaccination to the initial response At the time of analysis. Functional activity in vitro At all point during treatment (as specified in the study schedule) Adverse events related to potential cardiotoxicity Throughout the study Unsolicited adverse events (serious and non-serious) At any time during the study Laboratory values: hematological and biochemical variables (including coagulation). at all point during treatment as specified in the study schedule Mixed response At each tumor evaluation (Visits 7, 14 and 21) Electrocardiographic results at the end of cycle 1 and cycle 2 and at first follow-up visit Stable disease At each tumor evaluation (Visits 7, 14 and 21) Time to disease progression At the time of analysis. Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity. At all point during treatment (as specified in the study schedule) Frequency of cellular immune response in vitro to dHER2, HER2 ECD and HER2 ICD At all point during treatment (as specified in the study schedule) Any documented toxicity At any time during the study The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented At the time of analysis. Adverse events of Grades 3 and 4 Throughout the study Solicited local and general signs and symptoms (recorded by the patients on diary cards) During a period of four days following each administration of study vaccine Unsolicited serious adverse events At any time during the study Left ventricular ejection fraction At screening and at appropriate intervals during treatment. Vital signs. at each administration Results of physical examination At each visit
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇪Lima, Peru