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

NCT01492101 | Completed Phase 3 Results DMC

• 1 other identifier: 11-PIR-11
• Study Type: interventional
• Target: 852
• Locations: 11 countries
• Sites: 153

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.

Conditions

Locally Recurrent Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (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.

  36 Months

Secondary Outcomes (12)

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

  Up to 38 months.

• Clinical Benefit Rate (CBR): ITT Population

  Up to 38 months.

• Duration of Response (DOR): Efficacy Evaluable Population

  Up to 38 months.

• Incidence of Dose Reductions: Safety Population

  Up to 38 months.

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

  Up to 39 months

Study Arms (2)

NKTR-102

EXPERIMENTAL

Drug: NKTR-102

Physician's Treatment of Choice

ACTIVE COMPARATOR

Drug: Treatment of Physician's Choice (TPC)

Interventions

NKTR-102 DRUG

145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle.

NKTR-102

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

Physician's Treatment of Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (153)

Arizona Oncology Associates, PC - NAHOA

Flagstaff, Arizona, 86001, United States

Location

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

Burbank, California, 91505, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

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

Oxnard, California, 93030, United States

Location

Wilshire Oncology Medical Group, Inc.

Pasadena, California, 91105, United States

Location

Desert Hematology Oncology Medical Group

Rancho Mirage, California, 92270, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Kaiser Permanente

Vallejo, California, 94589, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Pre clinical Science Bldg LR3

Washington D.C., District of Columbia, 20007, United States

Location

Medstar

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34592, United States

Location

Northeast Georgia Cancer Care

Athens, Georgia, 30607, United States

Location

Peachtree Hematology Oncology Consultants

Atlanta, Georgia, 30318, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Central Georgia Cancer Care

Macon, Georgia, 31201, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Summit Cancer Care, P.C.

Savannah, Georgia, 31405, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Oncology Specialists

Niles, Illinois, 60714, United States

Location

Illinois Cancer Care, P.C.

Peoria, Illinois, 61547, United States

Location

IU Health Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Hall-Perrine Cancer Center, 3rd Floor

Cedar Rapids, Iowa, 52403, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, 66210, United States

Location

Louisville Oncology Clinical Research Program

Louisville, Kentucky, 40207, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Frontier Cancer Center and Blood Institute

Billings, Montana, 59102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hematology-Oncology Associates of Northern NJ, PA

Morristown, New Jersey, 07962, United States

Location

The cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Cooper University Hospital

Voorhees Township, New Jersey, 08043, United States

Location

UNM Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Cornell University

New York, New York, 10065, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Monte fiore

The Bronx, New York, 10461, United States

Location

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

The Bronx, New York, 10469, United States

Location

Carolinas Hematology Oncology Associates

Charlotte, North Carolina, 28202, United States

Location

DUMC, Duke South

Durham, North Carolina, 27710, United States

Location

Sanford Research/USD

Fargo, North Dakota, 58122, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0502, United States

Location

Comprehensive Breast Cancer

Columbus, Ohio, 43212, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 45042, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97225, United States

Location

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Cancer Centers of the Carolinas

Easley, South Carolina, 29640, United States

Location

Sanford Research/USD

Sioux Falls, South Dakota, 57104, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Abilene

Abilene, Texas, 79606, United States

Location

Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology-Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology-Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology-Denton South

Denton, Texas, 76210, United States

Location

Texas Oncology-Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology-Lewisville

Lewisville, Texas, 75067, United States

Location

Texas Oncology-Mesquite

Mesquite, Texas, 75150, United States

Location

Texas Oncology-Midland Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology, P.A. - Plano

Plano, Texas, 92270, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology-Tyler

Tyler, Texas, 75702, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

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

Salem, Virginia, 24153, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Cancer TEAM Bellin Health

Green Bay, Wisconsin, 54313, United States

Location

Institut Jules Bordet

Brussels, 2-2-541-72-26, Belgium

Location

GHdC - Site Notre Dame

Charleroi, 6000, Belgium

Location

Universtair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent Medische Oncologie

Ghent, 9000, Belgium

Location

UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège- Site du Sart Tilman

Liège, 4000, Belgium

Location

Centre Hospitalier Universitaire Ambroise Paré

Mons, 7000, Belgium

Location

GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY

Wilrijk, 2610, Belgium

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Odette Cancer Centre OCC Clinical Research

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

MUHC- Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Hôpital Charles-LeMoyne - CICM

Québec, J4V 2H1, Canada

Location

Institut Bergonie Service Oncologie Médicale

Bordeaux, 33076, France

Location

Sorecoh

Le Mans, 72000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Paoli Calmettes, Service Pharmacie

Marseille, 13273, France

Location

Centra Regional de Lutte contre le Cancer

Montpellier, 34298, France

Location

Institut Curie, UGEC

Paris, 75005, France

Location

Hopital Tenon Service oncologie médicale

Paris, 75020, France

Location

Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie Gustave Roussy

Villejuif, 94805, France

Location

Klinikum St. Marien Amberg

Amberg, Germany

Location

Onkoplus

Berlin, 14195, Germany

Location

Oncoresearch

Dortmund, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Wilhelm-Anton-Hospital gGmbH

Goch, 47574, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Ulm, Frauenklinik

Ulm, 89075, Germany

Location

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

Bari, 700124, Italy

Location

Via Olgettina

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica

Pisa, 56126, Italy

Location

Oncologia Ospedale Infermi- Viale

Rimini, 47923, Italy

Location

Istituto Nazionale tumori Regina Elena IRCCS

Roma, 144, Italy

Location

VUmc

Amsterdam, 1081, Netherlands

Location

MUMC

Maastricht, 6229, Netherlands

Location

Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

Leningrad Regional Oncology Dispensary

Kuz'molovskiy, 188663, Russia

Location

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

Moscow, 115478, Russia

Location

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

Saint Petersburg, 195271, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

Scientific Research Oncology Institute named after N.N. Petrov

Saint Petersburg, 197758, Russia

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

Samsung Medical Center

Irwon-dong, Seoul, 135-710, South Korea

Location

Hematology-oncology Department, Ajou University Hospital

Sŏwŏn, Suwon, 443-721, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Hematology-oncology Department, Ewha Womans University Mokdong Hospital

Seoul, 120-750, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Seoul National University Hospital,

Soeul, 110-744, South Korea

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

ICO l´Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MD Anderson Cancer Center Arturo

Madrid, 28033, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Sant Joan de Reus

Tarragona, 43204, Spain

Location

Clinical Trials Unit, Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Beaston Oncology Center

Glasgow, G12 ONY, United Kingdom

Location

St James University Hospital

Leeds, LS97TF, United Kingdom

Location

NCRN

London, EC1A 7BE, United Kingdom

Location

The Christie Hospitals NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Cancer Clinical Trials Centre, Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 30957581 DERIVED

• 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.

  PMID: 28612225 DERIVED

• 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.

  PMID: 28360015 DERIVED

• 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.

  PMID: 26482278 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

etirinotecan pegol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Alison Hannah, MD
• Organization: Nektar

AHannah@nektar.com

Study Officials

• Alison Hannah, MD

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Locations

KR (8); DE (7); NL (3); GB (7); ES (7); BE (8); CA (6); US (88); FR (9); IT (5); RU (5)