Conditions: Tumor Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: NKTR-102 arm 2: NKTR-102

Interventions: intervention 1: NKTR-102 intervention 2: NKTR-102
Intervention descriptions: intervention 1: NKTR-102 given on a q14 day schedule intervention 2: NKTR-102 given on a q21 day schedule

Protocol document: