The BEACON Study (Breast Cancer Outcomes With NKTR-102) (BEACON)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01492101 |
|
Recruitment Status
:
Completed
First Posted
: December 14, 2011
Last Update Posted
: August 4, 2016
|
Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | June 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures
:
- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes 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.
Information from the National Library of Medicine
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
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 | |
| Medstar | |
| Washington DC, District of Columbia, United States, 20010 | |
| Pre clinical Science Bldg LR3 | |
| Washington, District of Columbia, United States, 20007 | |
| 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 | |
| Peachtree Hematology Oncology Consultants | |
| Atlanta, Georgia, United States, 30318 | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| 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 | |
| Washington University in St. Louis | |
| St. Louis, Missouri, United States, 63110 | |
| Missouri Baptist Medical Center | |
| St. Louis, Missouri, United States, 63131 | |
| 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 | |
| Odette Cancer Centre OCC Clinical Research | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| CHUM-Hopital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| MUHC- Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G1A4 | |
| 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 | |
| Hematology-oncology Department, Ewha Womans University Mokdong Hospital | |
| Seoul, Korea, Republic of, 120-750 | |
| Severance Hospital, Yonsei University Health System | |
| Seoul, Korea, Republic of, 120-752 | |
| 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 | |
| Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways" | |
| St. Petersburg, Russian Federation, 195271 | |
| St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary" | |
| St. Petersburg, Russian Federation, 197022 | |
| 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 | |
| MD Anderson Cancer Center Arturo | |
| Madrid, Spain, 28033 | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nektar Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01492101 History of Changes |
| Other Study ID Numbers: |
11-PIR-11 |
| First Posted: | December 14, 2011 Key Record Dates |
| Last Update Posted: | August 4, 2016 |
| Last Verified: | August 2016 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |