The BEACON Study (Breast Cancer Outcomes With NKTR-102) (BEACON)
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.
|Locally Recurrent Breast Cancer Metastatic Breast Cancer||Drug: NKTR-102 Drug: Treatment of Physician's Choice (TPC)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Overall Survival [ Time Frame: 36 Months ]To compare overall survival (OS) of patients who received NKTR-102 given once every 21 days (q21d) to patients who received Treatment of Physicians Choice (TPC) selected from the following list of seven single agent intravenous therapies: eribulin, ixabepilone,vinorelbine, gemcitabine, paclitaxel, docetaxel or nab-paclitaxel
|Study Start Date:||December 2011|
|Study Completion Date:||June 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.
|Active Comparator: Physician's Treatment of Choice||
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492101
Show 153 Study Locations
|Study Director:||Ivan Gergel, MD||Nektar Therapeutics|