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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01492101
First received: December 12, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Locally Recurrent Breast Cancer
Metastatic Breast Cancer
Drug: NKTR-102
Drug: Treatment of Physician's Choice (TPC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 840
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102 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.
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492101

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Associates, PC - NAHOA
Flagstaff, Arizona, United States, 86001
United States, California
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center
Burbank, California, United States, 91505
University of Southern California
Los Angeles, California, United States, 90033
PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Wilshire Oncology Medical Group, Inc.
Pasadena, California, United States, 91105
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
University of California San Francisco
San Francisco, California, United States, 94143
Stanford University School of Medicine
Stanford, California, United States, 94305
Kaiser Permanente
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, District of Columbia
Pre clinical Science Bldg LR3
Washington, District of Columbia, United States, 20007
Medstar
Washington DC, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
University of Miami School of Medicine
Miami, Florida, United States, 33136
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Research Institute
Plantation, Florida, United States, 33324
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34592
United States, Georgia
Northeast Georgia Cancer Care
Athens, Georgia, United States, 30607
Emory University
Atlanta, Georgia, United States, 30322
Peachtree Hematology Oncology Consultants
Atlanta, Georgia, United States, 30318
Central Georgia Cancer Care
Macon, Georgia, United States, 31201
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
Summit Cancer Care, P.C.
Savannah, Georgia, United States, 31405
United States, Illinois
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Oncology Specialists
Niles, Illinois, United States, 60714
Illinois Cancer Care, P.C.
Peoria, Illinois, United States, 61547
United States, Indiana
IU Health Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Hall-Perrine Cancer Center, 3rd Floor
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Kansas City Cancer Center
Overland Park, Kansas, United States, 66210
United States, Kentucky
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States, 40207
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
St. Cloud, Minnesota, United States, 56303
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Montana
Frontier Cancer Center and Blood Institute
Billings, Montana, United States, 59102
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States, 07962
The cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Cooper University Hospital
Voorhees, New Jersey, United States, 08043
United States, New Mexico
UNM Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Monte fiore
Bronx, New York, United States, 10461
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Beth Israel Medical Center
New York City, New York, United States, 10003
Cornell University
New York City, New York, United States, 10065
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States, 28202
DUMC, Duke South
Durham, North Carolina, United States, 27710
United States, North Dakota
Sanford Research/USD
Fargo, North Dakota, United States, 58122
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502
Comprehensive Breast Cancer
Columbus, Ohio, United States, 43212
Signal Point Clinical Research Center
Middletown, Ohio, United States, 45042
United States, Oregon
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97225
United States, Pennsylvania
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Cancer Centers of the Carolinas
Easley, South Carolina, United States, 29640
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Abilene
Abilene, Texas, United States, 79606
Texas Oncology-Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Oncology-Bedford
Bedford, Texas, United States, 76022
Texas Oncology-Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Denton South
Denton, Texas, United States, 76210
Texas Oncology-Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology-Memorial City
Houston, Texas, United States, 77024
Texas Oncology-Lewisville
Lewisville, Texas, United States, 75067
Texas Oncology-Mesquite
Mesquite, Texas, United States, 75150
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology, P.A. - Plano
Plano, Texas, United States, 92270
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology - Sherman
Sherman, Texas, United States, 75090
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Cancer Care Northwest
Spokane, Washington, United States, 99202
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Cancer TEAM Bellin Health
Green Bay, Wisconsin, United States, 54313
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 2-2-541-72-26
GHdC - Site Notre Dame
Charleroi, Belgium, 6000
Universtair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
UZ Gent Medische Oncologie
Gent, Belgium, 9000
UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liège- Site du Sart Tilman
Liège, Belgium, 4000
Centre Hospitalier Universitaire Ambroise Paré
Mons,, Belgium, 7000
GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY
Wilrijk, Belgium, 2610
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Odette Cancer Centre OCC Clinical Research
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
MUHC- Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
CHUM-Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Canada
Hôpital Charles-LeMoyne - CICM
Québec, Canada, J4V 2H1
France
Institut Bergonie Service Oncologie Médicale
Bordeaux, France, 33076
Centre Oscar Lambret
Cedex, France, 95020
Sorecoh
Le Mans, France, 72000
Institut Paoli Calmettes, Service Pharmacie
Marseille, France, 13273
Centra Regional de Lutte contre le Cancer
Montpellier, France, 34298
Institut Curie, UGEC
Paris, France, 75005
Hopital Tenon Service oncologie médicale
Paris, France, 75020
Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Saint Herblain, France, 44805
Institut de Cancérologie Gustave Roussy
Villejuif, France, 94805
Germany
Klinikum St. Marien Amberg
Amberg, Germany
Onkoplus
Berlin, Germany, 14195
Oncoresearch
Dortmund, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Wilhelm-Anton-Hospital gGmbH
Goch, Germany, 47574
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum Ulm, Frauenklinik
Ulm, Germany, 89075
Italy
Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale
Bari, Italy, 700124
Via Olgettina
Milano, Italy, 20132
Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica
Pisa, Italy, 56126
Oncologia Ospedale Infermi- Viale
Rimini, Italy, 47923
Istituto Nazionale tumori Regina Elena IRCCS
Roma, Italy, 144
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
Samsung Medical Center
Gangnam-Gu, Seoul, Korea, Republic of, 135-710
Asan Medical Center
Songpagu, Soeul, Korea, Republic of, 138-736
Hematology-oncology Department, Ajou University Hospital
Yeongtong-gu, Suwon, Korea, Republic of, 443-721
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 463-707
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Hematology-oncology Department, Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 120-750
Seoul National University Hospital,
Soeul, Korea, Republic of, 110-744
Netherlands
VUmc
Amsterdam, Netherlands, 1081
MUMC
Maastricht, Netherlands, 6229
Tweesteden Ziekenhuis
Tilburg, Netherlands
Russian Federation
Leningrad Regional Oncology Dispensary
Leningrad, Russian Federation, 188663
State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"
Moscow, Russian Federation, 115478
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, Russian Federation, 197758
St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"
St. Petersburg, Russian Federation, 197022
Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"
St. Petersburg, Russian Federation, 195271
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
ICO l´Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
MD Anderson Cancer Center Arturo
Madrid, Spain, 28033
Hospital Sant Joan de Reus
Tarragona, Spain, 43204
United Kingdom
Clinical Trials Unit, Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Beaston Oncology Center
Glasgow, United Kingdom, G12 ONY
St James University Hospital
Leed, United Kingdom, LS97TF
NCRN
London, United Kingdom, EC1A 7BE
The Christie Hospitals NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Cancer Clinical Trials Centre, Weston Park Hospital
South Yorkshire, United Kingdom, S10 2SJ
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01492101     History of Changes
Other Study ID Numbers: 11-PIR-11
Study First Received: December 12, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014