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

Tracking Information
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; (submitted: August 2, 2013)	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
Original Primary Outcome Measures ICMJE; (submitted: December 12, 2011)	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
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.
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
Condition ICMJE	Locally Recurrent Breast Cancer; Metastatic Breast Cancer
Intervention ICMJE	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
Study Arms	Experimental: NKTR-102 Intervention: Drug: NKTR-102; Active Comparator: Physician's Treatment of Choice Intervention: Drug: Treatment of Physician's Choice (TPC)
Publications *	Cortés J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial. Breast Cancer Res Treat. 2017 Sep;165(2):329-341. doi: 10.1007/s10549-017-4304-7. Epub 2017 Jun 13. Erratum in: Breast Cancer Res Treat. 2017 Nov;166(1):327-328.; Twelves C, Cortés J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Rugo HS. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial. Eur J Cancer. 2017 May;76:205-215. doi: 10.1016/j.ejca.2017.02.011. Epub 2017 Mar 27.; Perez EA, Awada A, O'Shaughnessy J, Rugo HS, Twelves C, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J. Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1556-1568. doi: 10.1016/S1470-2045(15)00332-0. Epub 2015 Oct 22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 2, 2016)	852
Original Estimated Enrollment ICMJE; (submitted: December 12, 2011)	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): Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated; Patient can have either measurable or non-measurable disease by RECIST.; Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine; Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.; Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.; Adequate hematopoietic, liver and kidney functions. Exclusion Criteria (major highlights): Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.; Patient with any major surgery within 28 days prior to randomization.; Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).; Patient with prior treatment for cancer with a camptothecin derivative.; Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.; Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.; Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.; Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.; Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.; Patients with significant cardiovascular impairment.
Sex/Gender	Sexes Eligible for Study: Female
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	Study Director: Ivan Gergel, MD Nektar Therapeutics
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