Conditions: Locally Recurrent Breast Cancer Metastatic Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 852
Healthy volunteers: no

Brief summary:
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: NKTR-102 intervention 2: Treatment of Physician's Choice (TPC)
Intervention descriptions: intervention 1: 145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle. intervention 2: One of the following Treatment of Physician Choice will be administered per standard of care:

eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel

Protocol document: