NCT01492101

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 852 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Recurrent Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	NKTR-102	145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle.
DRUG	Treatment of Physician's Choice (TPC)	One of the following Treatment of Physician Choice will be administered per standard of care: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2011-12-14
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

153 sites across 11 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Russia, South Korea, Spain, United Kingdom