GSK-100633

Study Sponsor: GSK

Study Title

A multicenter, open-label Phase I/II trial of the safety and efficacy of the dHER2 recombinant protein combined with immunological adjuvant AS15 in patients with metastatic breast cancer overexpressing HER2/neu

Medicine or Vaccine (generic name)

SB719125

Sponsor Identification Number

100633

Trial Registry Identification Number(#'s)

NCT00140738 2004-001120-20

Medical Condition

Neoplasms, Breast

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=100633

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT00140738

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2004-001120-20

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

September 2017