The BEACON Study (Breast Cancer Outcomes With NKTR-102) (BEACON)
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|ClinicalTrials.gov Identifier: NCT01492101|
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : August 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Locally Recurrent Breast Cancer Metastatic Breast Cancer||Drug: NKTR-102 Drug: Treatment of Physician's Choice (TPC)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||852 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||June 2016|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492101
Show 153 Study Locations
|Study Director:||Ivan Gergel, MD||Nektar Therapeutics|