Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer

简要总结

主要结局

次要结局

• Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study(Baseline to 16 weeks.)
• Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study(Baseline to 16 weeks)
• Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25(Weeks 9, 17, and 25)
• Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)(Baseline to end of study drug therapy (up to 53.86 weeks))
• Mean Plasma Concentration at Week 3(At pre-dose and 1, 3, 6 and 12 hours after each dose administration)
• Mean Plasma Concentration at Week 7(At pre-dose and 1, 3, 6 and 12 hours after each dose administration)
• Mean Change in Concentration of Collagen Type IV From Baseline(Baseline, Week 3 and Week 5)
• Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline(Baseline, Week 3 and Week 5)
• Percentage Change in Tumor Biomarkers(Baseline)
• Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity(Baseline)
• Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)(From start of study drug therapy up to 30 days after the last dose.)
• Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs(From start of study drug therapy up to 30 days after the last dose.)
• Most Frequent Drug-related Adverse Events (AEs)(From start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).(Throughout study, from start of study drug therapy up to 30 days after the last dose.)
• Number of Participants With Identified Electrocardiogram (ECG) Abnormalities(Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).)
• Number of Participants With Abnormal Vital Signs Measurements(At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks))