The BEACON Study (Breast Cancer Outcomes With NKTR-102)
NCT ID: NCT01492101
Last Updated: 2021-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
852 participants
INTERVENTIONAL
2011-12-31
2016-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NKTR-102
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.
Physician's Treatment of Choice
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Alison Hannah, MD
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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Arizona Oncology Associates, PC - NAHOA
Flagstaff, Arizona, United States
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center
Burbank, California, United States
University of Southern California
Los Angeles, California, United States
PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Wilshire Oncology Medical Group, Inc.
Pasadena, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University School of Medicine
Stanford, California, United States
Kaiser Permanente
Vallejo, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Pre clinical Science Bldg LR3
Washington D.C., District of Columbia, United States
Medstar
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Advanced Medical Specialties
Miami, Florida, United States
Florida Cancer Research Institute
Plantation, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Northeast Georgia Cancer Care
Athens, Georgia, United States
Peachtree Hematology Oncology Consultants
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
Summit Cancer Care, P.C.
Savannah, Georgia, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Oncology Specialists
Niles, Illinois, United States
Illinois Cancer Care, P.C.
Peoria, Illinois, United States
IU Health Simon Cancer Center
Indianapolis, Indiana, United States
Hall-Perrine Cancer Center, 3rd Floor
Cedar Rapids, Iowa, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Frontier Cancer Center and Blood Institute
Billings, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States
The cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Cooper University Hospital
Voorhees Township, New Jersey, United States
UNM Cancer Center
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Beth Israel Medical Center
New York, New York, United States
Cornell University
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Monte fiore
The Bronx, New York, United States
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care
The Bronx, New York, United States
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States
DUMC, Duke South
Durham, North Carolina, United States
Sanford Research/USD
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Comprehensive Breast Cancer
Columbus, Ohio, United States
Signal Point Clinical Research Center
Middletown, Ohio, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas
Easley, South Carolina, United States
Sanford Research/USD
Sioux Falls, South Dakota, United States
The West Clinic
Memphis, Tennessee, United States
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology-Abilene
Abilene, Texas, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology-Bedford
Bedford, Texas, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Denton South
Denton, Texas, United States
Texas Oncology-Fort Worth
Fort Worth, Texas, United States
Texas Oncology-Memorial City
Houston, Texas, United States
Texas Oncology-Lewisville
Lewisville, Texas, United States
Texas Oncology-Mesquite
Mesquite, Texas, United States
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, United States
Texas Oncology, P.A. - Plano
Plano, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology - Sherman
Sherman, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Cancer TEAM Bellin Health
Green Bay, Wisconsin, United States
Institut Jules Bordet
Brussels, , Belgium
GHdC - Site Notre Dame
Charleroi, , Belgium
Universtair Ziekenhuis Antwerpen
Edegem, , Belgium
UZ Gent Medische Oncologie
Ghent, , Belgium
UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège- Site du Sart Tilman
Liège, , Belgium
Centre Hospitalier Universitaire Ambroise Paré
Mons, , Belgium
GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY
Wilrijk, , Belgium
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Odette Cancer Centre OCC Clinical Research
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM-Hopital Notre-Dame
Montreal, Quebec, Canada
MUHC- Montreal General Hospital
Montreal, Quebec, Canada
Hôpital Charles-LeMoyne - CICM
Québec, , Canada
Institut Bergonie Service Oncologie Médicale
Bordeaux, , France
Sorecoh
Le Mans, , France
Centre Oscar Lambret
Lille, , France
Institut Paoli Calmettes, Service Pharmacie
Marseille, , France
Centra Regional de Lutte contre le Cancer
Montpellier, , France
Institut Curie, UGEC
Paris, , France
Hopital Tenon Service oncologie médicale
Paris, , France
Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie Gustave Roussy
Villejuif, , France
Klinikum St. Marien Amberg
Amberg, , Germany
Onkoplus
Berlin, , Germany
Oncoresearch
Dortmund, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Wilhelm-Anton-Hospital gGmbH
Goch, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Ulm, Frauenklinik
Ulm, , Germany
Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale
Bari, , Italy
Via Olgettina
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica
Pisa, , Italy
Oncologia Ospedale Infermi- Viale
Rimini, , Italy
Istituto Nazionale tumori Regina Elena IRCCS
Roma, , Italy
VUmc
Amsterdam, , Netherlands
MUMC
Maastricht, , Netherlands
Tweesteden Ziekenhuis
Tilburg, , Netherlands
Leningrad Regional Oncology Dispensary
Kuz'molovskiy, , Russia
State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"
Moscow, , Russia
Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"
Saint Petersburg, , Russia
St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"
Saint Petersburg, , Russia
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, , Russia
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Samsung Medical Center
Irwon-dong, Seoul, South Korea
Hematology-oncology Department, Ajou University Hospital
Sŏwŏn, Suwon, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Hematology-oncology Department, Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital,
Soeul, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
MD Anderson Cancer Center Arturo
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Sant Joan de Reus
Tarragona, , Spain
Clinical Trials Unit, Velindre Cancer Centre
Cardiff, , United Kingdom
Beaston Oncology Center
Glasgow, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
NCRN
London, , United Kingdom
The Christie Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Cancer Clinical Trials Centre, Weston Park Hospital
Sheffield, , United Kingdom
Countries
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References
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Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Cortes J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras 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.
Twelves C, Cortes J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras 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, Gomez-Pardo P, Schwartzberg LS, Dieras 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.
Other Identifiers
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11-PIR-11
Identifier Type: -
Identifier Source: org_study_id
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