乳腺癌TKI治疗ppt课件.pptVIP

Sunitinib in Combination with Docetaxel vs. Docetaxel Alone for the First-line Treatment of Advanced Breast Cancer Endpoints and Statistical Hypothesis Primary endpoint: PFS Hypothesis: 50% increase in median PFS (from 6 to 9 months) in ITT population (independent central review), based on 285 events, power of 90%, alpha error 0.025, one sided log-rank test Secondary endpoints PFS (investigator assessment) ORR, duration of response OS Safety Median follow-up: 18.0 months (95% CI: 17.6?18.4) Fatalities Phase 3 Trial of Sunitinib in Combination with Capecitabine vs. Capecitabine in Previously