title: When an interim analysis of randomized trial changes the practice in oncology: The lesson of adjuvant trastuzumab and the HERA trial.
abstract: About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.
authors.affiliation: Instituto Oncologic. Veneto IRCCS, Padua, Italy. jirillo@libero.it
authors.forename: Costanza
authors.initials: C
authors.lastname: De Rossi
authors.forename: Antonella
authors.initials: A
authors.lastname: Brunello
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Jirillo
authors.forename: Antonio
authors.initials: A
authors.lastname: Jirillo
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D015982:Bias; D001943:Breast Neoplasms / Q000188:drug therapy; D017024:Chemotherapy, Adjuvant; D026661:Clinical Trials Data Monitoring Committees; D032984:Ethics, Research; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068878:Trastuzumab