Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer

"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:~* 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."

The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.