If at any point, the level of toxicity, particularly cardiac toxicity, becomes statistically higher in the vaccinated group, the study will be stopped. • Patient enrollment is unsatisfactory • Data recording are inaccurate or incomplete • Study protocol not followed 4.8 Data collection Basic demographic, pathologic, and relevant clinical information will be gathered on each patient and entered into an Electronic Data Capture (EDC) database. The URL for the EDC system is https://cancerinsight.eclinicalhosting.com/OpenClinica.