Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer
This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).
The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a protein that is commonly overexpressed in breast cancer. This protein is combined with the immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal formulation containing three immunostimulatory components.
Lapatinib is FDA approved for use in combination with capecitabine for the treatment of subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.
|Metastatic Breast Cancer||Biological: dHER2 + AS15 ASCI Drug: Lapatinib||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||A Monocentric, Open-label Phase I/II Study to Assess dHER2+AS15 Cancer Immunotherapeutic Given in Combination With Lapatinib to Patients With ErbB2 Overexpressing Metastatic Breast Cancer Refractory to Trastuzumab|
- The safety of dHER2+AS15 ASCI when administered in combination with Lapatinib measured by dose limiting toxicity. [ Time Frame: 26 weeks ]
- The specific humoral and cellular immune response induced by the dHER2+AS15 ASCI upon co-administration of Lapatinib [ Time Frame: 26 weeks ]
|Study Start Date:||July 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Biological: dHER2 + AS15 ASCI
- One vial with the lyophilized preparation containing 500 ug of recombinant dHER2 antigen combined with the immunostimulant.
- One vial with liquid adjuvant diluent. The final dHER2 + AS15 ASCI for administration is obtained by reconstitution of the lyophilized preparation with the adjuvant diluents. A dHER2 + AS15 ASCI dose consists of 0.5 ml.
- dHER2 ASCI
- dHER2 + AS15
Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine.
For each dose of 500µg of dHER2 + AS15 ASCI, two sterile glass vials will be supplied:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952692
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Michael Morse, MD||Duke University|