_Neven GYN ONCOL MBC UZKULeuven妇科肿瘤学和MBC P内文乌斯鲁汶大学课件.ppt

OngoingClinical Research TrialsMultidisciplinary Breast Centre Ten most frequently occuring tumours in Flanders, 2000 - 2001 Age-specific incidence of breast cancer in women, Flanders, 1997-2001 May be the incidence will come down? I. OngoingClinical Trials I. Clinical Trials Recently Closed Clinical Trials Recruiting Clinical Trials Future Clinical Trials Recruiting Clinical Trials OngoingClinical Trials IBIS-2Recruiting Centres St.Luc Brussel St.Pierre Brussel VUB Brussel Virga Jesse Hasselt St.Elisabeth Namen St.Augustinus Wilrijk Erasmus Brussel Bordet Brussel Heilig Hart Leuven OLVrouwZH Aalst ZOL Genk Clinique St.Pierre Ottignies CHR Citadelle Luik Brugmann Brussel Centre Hospitalier de l’Ardenne Recruiting Clinical Trials First Line: TTP Benefit of Fulvestrant over Tamoifenin ER+ PgR+ Patients* Fulvestrant 250 mg/month Provides Long-term Downregulation of ER Levels Fulvestrant induces dose-related ER downregulation(PgR and Ki67)* Finder-II Current Future Clinical Trials?Targeted Therapies Two Targets, One DrugLapatinib Profile Lapatinib is a novel oral dual-tyrosine kinase inhibitor with specificity for the ErbB-1 andErbB-2 receptors Belongs to the 4-anilinoquinazoline class of tyrosine kinase inhibitors Binds reversibly to the cytoplasmic ATP-binding site of the kinase, thereby preventing receptor phosphorylation and activation ALTTO STUDY DESIGN Four-arm, randomised, open-label and multicentre study in women with primary breast cancer that over expresses or amplifies HER2. Sample Size 8000 patients Primary Endpoint: DFS Secondary Endpoints OS TTR (time to recurrence) TTDR (Time to distant recurrence) Safety and tolerability Proposed start 2Q07 Study duration: 5 years (4 years for enrolment and 1 year as follow-up) 2 Interim analyses (at 600 and 1000 DFS events, approximately) ALTTO STUDY DESIGN 4 Arms: Trastuzumab for 52 wks Lapatinib for 52 wks Trastuzumab + Lapatinib for 52 wks Trastuzumab for 12 wks, 6 wk washout, Lapatinib for 34 wks