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
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Tracking Information | ||||
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First Submitted Date ICMJE | December 12, 2011 | |||
First Posted Date ICMJE | December 14, 2011 | |||
Last Update Posted Date | August 4, 2016 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
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, gemcitabline, paclitaxel, docetaxel or nab-paclitaxel
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Change History | Complete list of historical versions of study NCT01492101 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The BEACON Study (Breast Cancer Outcomes With NKTR-102) | |||
Official Title ICMJE | 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 | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
852 | |||
Original Estimated Enrollment ICMJE |
840 | |||
Actual Study Completion Date | June 2016 | |||
Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria (major highlights):
Exclusion Criteria (major highlights):
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Russian Federation, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01492101 | |||
Other Study ID Numbers ICMJE | 11-PIR-11 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Nektar Therapeutics | |||
Study Sponsor ICMJE | Nektar Therapeutics | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Nektar Therapeutics | |||
Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |