title: Clinical trial methods to discover and validate predictive markers for treatment response in cancer.
abstract: Although postoperative chemotherapy in the treatment of cancer appears to have reached the limit of cytoreduction, this may be due to chemotherapeutic agents that are administered nonselectively rather than attainment of the true limit of cytoreduction. Molecular profiles of tumor cells may determine tumor response to chemotherapy, and therefore the selective use of chemotherapy based on prediction will ultimately provide a cure for breast cancer. In this paper, design strategies for clinical trials aimed at disclosing predictive markers are discussed.
authors.affiliation: Division of Pathology, National Surgical Adjuvant Breast and Bowel Project, Four Allegheny Center, Pittsburgh, PA 15212, USA. soonmyung.paik@nsabp.org
authors.forename: Soonmyung
authors.initials: S
authors.lastname: Paik
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis / Q000378:metabolism*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000378:metabolism / Q000601:surgery; D011237:Predictive Value of Tests; D011300:Preoperative Care / Q000379:methods; D011379:Prognosis; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor