Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients
with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based
treatment in the metastatic setting.
Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered
at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d
schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may
be evaluated in this study with approximately 35 patients enrolled in each treatment arm.