Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatme
 

http://clinicaltrials.gov/show/NCT01220128

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

• Phase I segment of the study: occurrence of severe toxicities. [ Time Frame: On a continuous basis during the whole study duration (Day 0 to 36 months after concluding visit-30 days post-surgery). ] [ Designated as safety issue: No ]
  
• Phase I segment of the study: immunogenicity to constituent of the investigational immunotherapy. [ Time Frame: Post study treatment Dose 4, evaluated using a blood sample collected at Visit 5, after 13 weeks of treatment. ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: occurrence of severe toxicities. [ Time Frame: On a continuous basis during the whole study duration (Day 0 to 36 months after concluding visit). ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: occurrence of adverse events and serious adverse events. [ Time Frame: On a continuous basis during the study treatment period and ending 30 days after the last study treatment administration (Week 16 or 22 depending on the chemotherapy regimen). ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: occurrence of serious adverse events related to study treatment. [ Time Frame: On a continuous basis during the whole study duration (Day 0 to 36 months after concluding visit). ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: Immunogenicity to constituent of the investigational immunotherapy. [ Time Frame: At treatment start, after 10, 13 and 16 weeks of treatment, or after 10, 13, 19 and 22 weeks of treatment depending on the treatment regimen, at concluding Visit, as well as after 6 and 12 months after concluding visit. ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: clinical activity (The pathological response in the breast and axillary nodes at the definitive surgery). [ Time Frame: At surgery (pathological complete response). ] [ Designated as safety issue: No ]
  
• Phase II segment of the study: other indicators of clinical activity (Disease free survival and Overall survival). [ Time Frame: From surgery onwards until the end of the post study contact (6 years after the concluding visit). ] [ Designated as safety issue: No ]
  

Estimated Enrollment: 180 Study Start Date: April 2011 Estimated Study Completion Date: October 2018 Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)