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Locally Recurrent Breast CancerPhase 3BEACONNCT01492101

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

A Phase 3 study testing NKTR-102 and Treatment of Physician's Choice (TPC) in people with Locally Recurrent Breast Cancer and Metastatic Breast Cancer, run by Nektar Therapeutics at 153 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
NKTR-102 and Treatment of Physician's Choice (TPC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
852 participants
Where
153 sitesin 11 countries
Study dates
Dec 2011to Jun 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

153 sites in 11 countries.

153 sites in 11 countries

United States88 sites

  • Texas Oncology-Abilene

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • UNM Cancer Center

    Albuquerque, New Mexico, 87106

  • Northeast Georgia Cancer Care

    Athens, Georgia, 30607

  • Peachtree Hematology Oncology Consultants

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology-Bedford

    Bedford, Texas, 76022

  • Frontier Cancer Center and Blood Institute

    Billings, Montana, 59102

  • Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center

    Burbank, California, 91505

  • Hall-Perrine Cancer Center, 3rd Floor

    Cedar Rapids, Iowa, 52403

  • Carolinas Hematology Oncology Associates

    Charlotte, North Carolina, 28202

  • University of Virginia

    Charlottesville, Virginia, 22908

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0502

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Comprehensive Breast Cancer

    Columbus, Ohio, 43212

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology-Denton South

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • DUMC, Duke South

    Durham, North Carolina, 27710

  • Cancer Centers of the Carolinas

    Easley, South Carolina, 29640

  • Sanford Research/USD

    Fargo, North Dakota, 58122

  • Arizona Oncology Associates, PC - NAHOA

    Flagstaff, Arizona, 86001

  • Texas Oncology-Fort Worth

    Fort Worth, Texas, 76104

  • Cancer TEAM Bellin Health

    Green Bay, Wisconsin, 54313

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • IU Health Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Texas Oncology-Lewisville

    Lewisville, Texas, 75067

  • University of Southern California

    Los Angeles, California, 90033

  • Louisville Oncology Clinical Research Program

    Louisville, Kentucky, 40207

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • Texas Oncology-Mesquite

    Mesquite, Texas, 75150

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Texas Oncology-Midland Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey, 07962

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • The cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Beth Israel Medical Center

    New York, New York, 10003

  • Cornell University

    New York, New York, 10065

  • Oncology Specialists

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Kansas City Cancer Center

    Overland Park, Kansas, 66210

  • PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Wilshire Oncology Medical Group, Inc.

    Pasadena, California, 91105

  • Illinois Cancer Care, P.C.

    Peoria, Illinois, 61547

  • Texas Oncology, P.A. - Plano

    Plano, Texas, 92270

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34592

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97225

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • University of California San Francisco

    San Francisco, California, 94143

  • Summit Cancer Care, P.C.

    Savannah, Georgia, 31405

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Texas Oncology - Sherman

    Sherman, Texas, 75090

  • Sanford Research/USD

    Sioux Falls, South Dakota, 57104

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stanford University School of Medicine

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Monte fiore

    The Bronx, New York, 10461

  • Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente

    Vallejo, California, 94589

  • Cooper University Hospital

    Voorhees Township, New Jersey, 08043

  • Pre clinical Science Bldg LR3

    Washington D.C., District of Columbia, 20007

  • Medstar

    Washington D.C., District of Columbia, 20010

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

France9 sites

  • Institut Bergonie Service Oncologie Médicale

    Bordeaux, 33076

  • Sorecoh

    Le Mans, 72000

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Paoli Calmettes, Service Pharmacie

    Marseille, 13273

  • Centra Regional de Lutte contre le Cancer

    Montpellier, 34298

  • Institut Curie, UGEC

    Paris, 75005

  • Hopital Tenon Service oncologie médicale

    Paris, 75020

  • Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium8 sites

  • Institut Jules Bordet

    Brussels, 2-2-541-72-26

  • GHdC - Site Notre Dame

    Charleroi, 6000

  • Universtair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Gent Medische Oncologie

    Ghent, 9000

  • UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège- Site du Sart Tilman

    Liège, 4000

  • Centre Hospitalier Universitaire Ambroise Paré

    Mons, 7000

  • GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY

    Wilrijk, 2610

Other trials in Belgium

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-711

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 463-707

  • Samsung Medical Center

    Irwon-dong, Seoul, 135-710

  • Hematology-oncology Department, Ewha Womans University Mokdong Hospital

    Seoul, 120-750

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Asan Medical Center

    Seoul, 138-736

  • Seoul National University Hospital,

    Soeul, 110-744

  • Hematology-oncology Department, Ajou University Hospital

    Sŏwŏn, Suwon, 443-721

Other trials in South Korea

Germany7 sites

  • Klinikum St. Marien Amberg

    Amberg

  • Onkoplus

    Berlin, 14195

  • Oncoresearch

    Dortmund

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Wilhelm-Anton-Hospital gGmbH

    Goch, 47574

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Ulm, Frauenklinik

    Ulm, 89075

Other trials in Germany

Spain7 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • ICO l´Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • MD Anderson Cancer Center Arturo

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Sant Joan de Reus

    Tarragona, 43204

Other trials in Spain

United Kingdom7 sites

  • Clinical Trials Unit, Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Beaston Oncology Center

    Glasgow, G12 ONY

  • St James University Hospital

    Leeds, LS97TF

  • NCRN

    London, EC1A 7BE

  • The Christie Hospitals NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Cancer Clinical Trials Centre, Weston Park Hospital

    Sheffield, S10 2SJ

Other trials in United Kingdom

Canada6 sites

  • CHUM-Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • MUHC- Montreal General Hospital

    Montreal, Quebec, H3G1A4

  • Hôpital Charles-LeMoyne - CICM

    Québec, J4V 2H1

  • Odette Cancer Centre OCC Clinical Research

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy5 sites

  • Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale

    Bari, 700124

  • Via Olgettina

    Milan, 20132

  • Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica

    Pisa, 56126

  • Oncologia Ospedale Infermi- Viale

    Rimini, 47923

  • Istituto Nazionale tumori Regina Elena IRCCS

    Roma, 144

Other trials in Italy

Russia5 sites

  • Leningrad Regional Oncology Dispensary

    Kuz'molovskiy, 188663

  • State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"

    Moscow, 115478

  • Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"

    Saint Petersburg, 195271

  • St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"

    Saint Petersburg, 197022

  • Scientific Research Oncology Institute named after N.N. Petrov

    Saint Petersburg, 197758

Other trials in Russia

Netherlands3 sites

  • VUmc

    Amsterdam, 1081

  • MUMC

    Maastricht, 6229

  • Tweesteden Ziekenhuis

    Tilburg

Other trials in Netherlands

About this study

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

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.

Being tested
NKTR-102, Treatment of Physician's Choice (TPC)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKTR-102Drug

    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)Drug

    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 groups in NCT01492101
Study groupRoleWhat they receive
NKTR-102ExperimentalNot described
Receives: Drug: NKTR-102
Physician's Treatment of ChoiceActive comparatorNot described
Receives: Drug: Treatment of Physician's Choice (TPC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population

    Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.

    Measured: 36 Months

Secondary outcomes (12)

  1. Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population

    PFS was defined as the time from the date of randomization to the earliest date of disease progression (assessed by the investigator according to RECIST version 1.1) or death due to any cause. PFS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. For subjects whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For subjects who received new anti-cancer therapy, the PFS time was censored at the start of the new anti-cancer therapy.

    Measured: Up to 38 months.

  2. Clinical Benefit Rate (CBR): ITT Population

    CBR was defined as the proportion of subjects with a CR, PR, or stable disease (SD) for at least 6 months (≥ 182 days).

    Measured: Up to 38 months.

  3. Duration of Response (DOR): Efficacy Evaluable Population

    DOR was defined as the time from first documented CR or PR until the earliest evidence of disease progression or death from any cause. Subjects who were alive without documented disease progression per RECIST version 1.1 were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease.

    Measured: Up to 38 months.

  4. Incidence of Dose Reductions: Safety Population

    Proportion of subjects who had a reduction in dose.

    Measured: Up to 38 months.

  5. Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population

    The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhoea, constipation, insomnia and dyspnoea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Measured: Up to 39 months

  6. QLQ-C30 Individual Scale, Change Over Time: ITT Population

    The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhea, constipation, insomnia and dyspnea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (from 1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Measured: From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.

  7. Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population

    The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items to assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Measured: Baseline

  8. BR23 Score Change Over Time: ITT Population

    The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.

    Measured: Up to 38 months.

  9. Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population pharmacokinetic (PK) model-derived mean AUC values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

    Measured: Up to 38 months.

  10. Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean Cmax values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

    Measured: Up to 38 months.

  11. Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27]

    Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population PK model-derived mean t½ values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution. The t½ of all analytes was primarily driven by NKTR-102. Thus, the NKTR-102 t½ of 37 days also applies to all NKTR-102 metabolites.

    Measured: Up to 38 months.

  12. Objective Response Rate (ORR): Efficacy Evaluable Population

    ORR was defined as the proportion of subjects with a complete response (CR) or a partial response (PR), assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 The analyses were performed for subjects in the efficacy evaluable population who had measurable disease as determined by the investigator at baseline.

    Measured: Up to 38 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionApr 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
852 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492101
Sponsor's protocol ID
11-PIR-11
Acronym
BEACON
Status last verified
May 2021
First submitted
12 Dec 2011
Last updated
1 Jun 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30957581

  • 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.

    PubMed 28612225

  • 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.

    PubMed 28360015

  • 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.

    PubMed 26482278

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NKTR-102 and Treatment of Physician's Choice (TPC) in people with Locally Recurrent Breast Cancer and Metastatic Breast Cancer, run by Nektar Therapeutics at 153 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, France, Belgium, South Korea, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population (time frame: 36 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492101, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.

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