AzTrials
AzTrials

Breast NeoplasmsPhase 3EMBRACANCT01945775

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

A Phase 3 study testing talazoparib and Physician's-Choice in people with Breast Neoplasms and BRCA 1 Gene Mutation, run by Pfizer at 362 sites in 16 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 purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
talazoparib and Physician's-Choice
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
431 participants
Where
362 sitesin 16 countries
Study dates
14 Oct 2013to 5 Mar 2021
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed carcinoma of the breast
  • Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
  • Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
  • No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
  • Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
  • Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Who cannot join

  • First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
  • Prior treatment with a PARP inhibitor (not including iniparib)
  • Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
  • Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
  • Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
  • Cytotoxic chemotherapy within 14 days before randomization
Show all 19Show fewer
  • Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
  • HER2 positive breast cancer
  • Active inflammatory breast cancer
  • CNS metastases
  • Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
  • Subjects with leptomeningeal carcinomatosis are not permitted
  • Prior malignancy except for any of the following:
  • Prior BRCA-associated cancer as long as there is no current evidence of the cancer
  • Carcinoma in situ or non-melanoma skin cancer
  • A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence
  • Known to be human immunodeficiency virus positive
  • Known active hepatitis C virus, or known active hepatitis B virus
  • Known hypersensitivity to any of the components of talazoparib

Trial locations and contacts

362 sites in 16 countries.

362 sites in 16 countries

United States207 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94509

  • Kaiser Permanente Medical Center Lab Drawing Station

    Antioch, California, 94531

  • The Center for Cancer and Blood Disorders

    Arlington, Texas, 76014

  • Hope Women's Cancer Centers

    Asheville, North Carolina, 28806

  • MH Mission Hospital, LLLP

    Asheville, North Carolina, 28806

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • Texas Oncology-South Austin

    Austin, Texas, 78745

  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • The Center for Cancer and Blood Disorders (Huguley)

    Burleson, Texas, 76028

  • Texas Oncology - Cedar Park

    Cedar Park, Texas, 78613

  • Novant Health Cancer Specialists

    Charlotte, North Carolina, 28204

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Southern Oncology Specialists

    Charlotte, North Carolina, 28262

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433

  • The West Clinic, P.C.

    Corinth, Mississippi, 38834

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Sylvester Comprehensive Cancer Center Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435-2150

  • Texas Oncology-El Paso Cancer Treatment Center Grandview

    El Paso, Texas, 79902

  • Texas Oncology-El Paso Cancer Treatment Center Gateway

    El Paso, Texas, 79915

  • Texas Oncology - El Paso Cancer Treatment Center Joe Battle

    El Paso, Texas, 79938

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Kaiser Permanente Medical Center Lab Drawing Station

    Fairfield, California, 94533-6901

  • The University of Kansas Cancer Center (Regulatory Office)

    Fairway, Kansas, 66205

  • Arizona Oncology Associates P.C. - NAHOA

    Flagstaff, Arizona, 86001

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Investigational Products Center (IPC)

    Fort Worth, Texas, 76177

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Minnesota Oncology Hematology, P.A.

    Fridley, Minnesota, 55432

  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Tennessee Oncology PLLC

    Gallatin, Tennessee, 37066

  • The West Clinic, P.C. d/b/a West Cancer Center

    Germantown, Tennessee, 38138

  • Kaiser Permanente Medical Center Lab Drawing Station

    Gilroy, California, 95020

  • Los Angeles Hematology Oncology Medical Group

    Glendale, California, 91204

  • Los Angeles Hematology Oncology Medical Group

    Glendale, California, 91206

  • Cancer And Hematology Centers Of Western Michigan

    Grand Rapids, Michigan, 49506

  • Marin Specialty Care

    Greenbrae, California, 94904

  • Comprehensive Cancer Centers Of Nevada

    Henderson, Nevada, 89052

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University Of Texas, Md Anderson Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Florida Cancer Specialists

    Hudson, Florida, 34667

  • Lake Norman Hematology Oncology Specialists

    Huntersville, North Carolina, 28078

  • Novant Health Huntersville Medical Center

    Huntersville, North Carolina, 28078

  • Southern Oncology Specialists

    Huntersville, North Carolina, 28078

  • Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)

    Indianapolis, Indiana, 46202

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Clinic

    Indianapolis, Indiana, 46290

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center(IPC)

    Irving, Texas, 75063

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32003

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32204

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32207

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32258

  • Cancer Specialists of North Florida

    Jacksonville Beach, Florida, 32250

  • The University of Kansas Cancer Center

    Kansas City, Kansas, 66112

  • The University of Kansas Cancer Center

    Kansas City, Missouri, 64131

  • The University of Kansas Cancer Center

    Kansas City, Missouri, 64154

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Florida Cancer Specialists

    Lady Lake, Florida, 32159

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • The University of Kansas Cancer Center

    Lee's Summit, Missouri, 64064

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Los Angeles Hematology Oncolgy Medical Group

    Los Angeles, California, 90017

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90057

  • Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

    Los Angeles, California, 90095-7349

  • Drug Management only: UCLA West Medical Pharmacy

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy, Attn: Steven L. Wong

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

    Los Angeles, California, 90095-7349

  • Regulatory Managment Only: TRIO-US Central Administration

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • TRIO-US Central Administration

    Los Angeles, California, 90095

  • UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

    Los Angeles, California, 90095

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Central Georgia Cancer Care, PC

    Macon, Georgia, 31201

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

  • Kaiser Permanente Medical Center Lab Drawing Station

    Martinez, California, 94553

  • Novant Health Cancer Specialists

    Matthews, North Carolina, 28105

  • Novant Health Matthews Medical Center

    Matthews, North Carolina, 28105

  • The West Clinic, P.C. d/b/a West Cancer Center

    Memphis, Tennessee, 38104

  • "University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"

    Miami, Florida, 33136

  • Sylvester Comprehensive Cancer Center Kendall

    Miami, Florida, 33176

  • Kaiser Permanente Medical Center Lab Drawing Station

    Milpitas, California, 95035-5491

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Kaiser Permanente Medical Center Lab Drawing Station

    Modesto, California, 95356

  • Lake Norman Hematology Oncology Specialists

    Mooresville, North Carolina, 28117

  • Kaiser Permanente Medical Center Lab Drawing Station

    Mountain View, California, 94041

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129

  • Kaiser Permanente Medical Center Lab Drawing Station

    Napa, California, 94558-3313

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37211

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • New York University Langone Medical Center

    New York, New York, 10016

  • Perlmutter Cancer Center

    New York, New York, 10016

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10021

  • Weill Cornell Medical College - New York-Presbyterian Hospital

    New York, New York, 10021

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065

  • Weill Cornell Breast Center

    New York, New York, 10065

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Kaiser Permanente Medical Center (clinic+DSL)

    Oakland, California, 94611

  • Kaiser Permanente Medical Center (Radiology)

    Oakland, California, 94611

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • The University of Kansas Cancer Center

    Overland Park, Kansas, 66210

  • Rocky Mountain Cancer Centers

    Parker, Colorado, 80138

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Cancer Center of Central Connecticut

    Plainville, Connecticut, 06062

  • Texas Oncology-Plano East

    Plano, Texas, 75075-7787

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324

  • Kaiser Permanente Medical Center Lab Drawing Station

    Pleasanton, California, 94558

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Rocky Mountain Cancer Centers

    Pueblo, Colorado, 81008

  • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates

    Redondo Beach, California, 90277

  • Kaiser Permanente Medical Center Lab Drawing Station

    Redwood City, California, 94063

  • Kaiser Permanente Medical Center (clinic+DSL)

    Roseville, California, 95661

  • Texas Oncology-Seton Williamson

    Round Rock, Texas, 78665

  • Cancer Specialists of North Florida

    Saint Augustine, Florida, 32086

  • Minnesota Oncology Hematology, P.A.

    Saint Paul, Minnesota, 55102-2389

  • Southern California Permanente Medical Group

    San Diego, California, 92120

  • UCSF - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building

    San Francisco, California, 94158

  • Kaiser Permanente Mission Bay Medical Center Lab Drawing Station

    San Francisco, California, 94518

  • Kaiser Permanente Medical Center Lab Drawing Station

    San Jose, California, 95110

  • Kaiser Permanente Medical Center (clinic+DSL)

    San Leandro, California, 94577

  • Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center

    San Luis Obispo, California, 93401

  • Ridley Tree Cancer Center

    Santa Barbara, California, 93105

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Kaiser Permanente Medical Center (clinic+DSL)

    Santa Clara, California, 95051

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Hematology Oncology

    Santa Monica, California, 90404

  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California, 90404

  • UCLA Santa Monica Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

  • Sutter North Bay Health Plaza

    Santa Rosa, California, 95403

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Sutter Santa Rosa Regional Hospital

    Santa Rosa, California, 95403

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Virginia G. Piper Cancer Pharmacy

    Scottsdale, Arizona, 85258

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167

  • Ridley Tree Cancer Center

    Solvang, California, 93463

  • Kaiser Permanente Medical Center (clinic+DSL)

    South San Francisco, California, 94080

  • The West Clinic, P.C. d/b/a West Cancer Center

    Southaven, Mississippi, 38671

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stanford Cancer Institute

    Stanford, California, 94305

  • Stanford Women's Cancer Center

    Stanford, California, 94305

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • UCLA Hematology/Oncology - Santa Clarita

    Valencia, California, 91355

  • Kaiser Permanente Medical Center (clinic+DSL)

    Vallejo, California, 94589

  • Northwest Cancer Specialists, P.C.(Admin Only)

    Vancouver, Washington, 98683

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Texas Oncology-Waco

    Waco, Texas, 76712

  • Kaiser Permanente Medical Center (clinic+DSL)

    Walnut Creek, California, 94596

  • Central Georgia Cancer Care, PC

    Warner Robins, Georgia, 31088-2259

  • The Center for Cancer and Blood Disorders

    Weatherford, Texas, 76086

  • The University of Kansas Cancer Center - Investigational Drug Services

    Westwood, Kansas, 66205

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

  • Southern California Permanente Medical Group

    Woodland Hills, California, 91367

Other trials in United States

Australia26 sites

  • River City Pharmacy

    Auchenflower, 4066

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Victoria Breast and Oncology Care

    East Melbourne, Victoria, 3002

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)

    Heidelberg West, Victoria, 3081

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Cancer Care SA PTY Ltd

    Kurralta Park, South Australia, 5037

  • Cancer Care SA trading as Icon Pharmacy Adelaide

    Kurralta Park, South Australia, 5037

  • Austin Health, The Austin Hospital

    Melbourne, Victoria, 3084

  • ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton

    Milton, Queensland, 4064

  • Icon Cancer Care

    Milton, 4066

  • Slade Pharmacy Mount Waverley

    Mount Waverley, Victoria, 3149

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Sir Charles Gairdner Hospital Lung Institute Of Western Australia

    Nedlands, Western Australia, 6009

  • Icon Cancer Care, Corporate Office

    South Brisbane, Queensland, 4101

  • ICON Cancer Care

    South Brisbane, Queensland, 4101

  • ICON Cancer Foundation

    South Brisbane, Queensland, 4101

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4104

  • Nova Pharmacy

    Wendouree, Victoria, 3353

  • Ballarat Oncology & Haematology Services Clinical Trials Unit

    Wendouree, Victoria, 3355

  • Ballarat Oncology & Haematology Services

    Wendouree, Victoria, 3355

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Poland20 sites

  • NZOZ Innowacyjna Medycyna

    Dobra, 72-003

  • Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej

    Gdansk, 80-211

  • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii

    Gdansk, 80-952

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach

    Gliwice, 44-101

  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice

    Katowice, 40-514

  • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu

    Katowice, 40-514

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, LODZ Province, 90-242

  • Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina

    Otwock, 05-400

  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 60-355

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

    Poznan, 60-569

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola

    Poznan, 60-569

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

    Poznan, 61-848

  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

    Poznan, 61-866

  • Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-111

  • Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-111

  • Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ

    Szczecin, 70-965

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i

    Warsaw, 02-781

  • Klinika Onkologii, Wojskowy lnstytut Medyczny

    Warsaw, 04-141

Other trials in Poland

Spain17 sites

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)

    Ávila, 05004

  • Hospital Universitari Germans Trias i Pujol

    Badalona Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, 12002

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Universitario de Canarias

    La Laguna Santa Cruz de Tenerife, 38320

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcon (Madrid), 28223

  • Corporacio Sanitaria Parc Tauli

    Sabadell Barcelona, 08208

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Germany16 sites

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum

    Berlin, 13595

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

    Dresden, Saxony, 01307

  • University Hospital Duesseldorf

    Düsseldorf, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum

    Essen, 45136

  • Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde

    Freiburg im Breisgau, 79106

  • Oncologie Unter Ems

    Leer, 26789

  • Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ

    Munich, Bavaria, 80639

  • Radiologicum

    Munich, Bavaria, 81331

  • IOZ Muenchen

    Munich, Bavaria, 81377

  • University of Munich (LMU), Grosshadern Hospital

    Munich, Bavaria, 81377

  • Radiologicum

    Munich, Bavaria, 81539

  • Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik

    Munich, 81675

  • Unifrauenklinik am Klinikum Suedstadt

    Rostock, 18059

  • Universitaetsfrauenklinik

    Ulm, 89075

Other trials in Germany

Brazil13 sites

  • Hospital do Cancer de Barretos - Fundacao Pio XII

    Barretos, São Paulo, 14784-400

  • Fundacao Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hopital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital da Cidade de Passo Fundo - HCPF

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Instituto de Oncologia de Piracicaba S/S Ltda.

    Piracicaba, São Paulo, 13419-155

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Uniao Brasileira de Educacao E Assistencia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional do Cancer Jose de Alencar Gomes da Silva

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Central de Quimioterapia Hospital do Cancer-INCA-HCIII

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Centro de Referencia da Saude da Mulher - Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

  • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.

    São Paulo, São Paulo, 01317-001

Other trials in Brazil

South Korea13 sites

  • Seoul National University Bundang Hospital

    Bundang-gu, Gyeonggi-do, 13620

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Centre

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

France11 sites

  • CHRU Jean Minjoz

    Besançon, 25030

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273 Cedex 9

  • Hopital Prive du Confluent

    Nantes BP 20215, 44202 Cedex 2

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Tenon

    Paris, 75020

  • Institut de Cancerologie de l'Ouest - Site Rene Gauducheau

    Saint-Herblain, 44805 Cedex

  • Hopitaux Universitaires de Strasbourg - Hopital Civil

    Strasbourg, 67200

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31059 Cedex 9

  • CHU Bretonneau Centre Henry Kaplan

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy11 sites

  • A.O.S.G. Moscati - Contrada Amoretta

    Avellino, AV, 83100

  • S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi

    Bologna, 1-40138

  • Ospedale Mater Salutis

    Legnago, VR, 37045

  • Ospedale S. Raffaelle di Milano

    Milan, MI, 20132

  • Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)

    Milan, I-20141

  • A.S.S.T. Monza

    Monza, Monza and Brianza, I-20900

  • A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo

    Monza, Monza Brianza, I-20900

  • La Maddalena Clinic For Cancer University Of Palermo

    Palermo, PA, 90146

  • A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.

    Pisa, PI, I-56126

  • Ospendale Sant'Andrea

    Roma, RM, 00189

  • Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica

    Roma, I-00128

Other trials in Italy

Israel8 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Oncology Institute, Rambam Health Care Campus

    Haifa, 31096

  • Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus

    Petah Tikva, 49100

  • Division of Oncology Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Assuta Medical Center

    Tel Aviv, 69710

  • Oncology Institute, Assuta Medical Center

    Tel Aviv, 69710

  • The Chaim sheba Medical Center

    Tel HaShomer, 5265601

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

United Kingdom6 sites

  • Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10

    Brighton, BN2 2BE

  • St James University Hospital

    Leeds, LS9 7TF

  • Sarah Cannon Research Institute UK

    London, England, W1G 6AD

  • Impretial College Healthcare NHS Trust

    London, W6 8RF

  • Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospital NHS Trust

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Taiwan4 sites

  • Changhua Christian Hospital

    Changhua, 500

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

Other trials in Taiwan

Ireland3 sites

  • Mater Misericordiae University Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

  • University Hospital Galway

    Galway

Other trials in Ireland

Russia3 sites

  • Gbuz Lood

    Leningrad, Leningradskaya Oblast', 188663

  • State Budgetary Institution of Healthcare "Republican Oncology dispensary"'

    Petrozavodsk, 185002/185007

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

Other trials in Russia

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • CHU Sart Tilman Liege

    Liège, B-4000

Other trials in Belgium

Ukraine2 sites

  • Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048

  • Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

    Sumy, 40005

Other trials in Ukraine

About this study

Official title: A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

Being tested
talazoparib, Physician's-Choice
Keywords
Breast cancer, BRCA mutation, PARP inhibitor, BRCA 1, BRCA 2
Medical subject headings
Breast Neoplasms

What participants receive

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

  • talazoparibDrug

    Until progression or unacceptable toxicity develops

  • Physician's-ChoiceDrug

    Capecitabine, Eribulin, Gemcitabine or Vinorelbine

Study groups in NCT01945775
Study groupRoleWhat they receive
talazoparibExperimentalPatient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
Receives: Drug: talazoparib
Physician's-ChoiceActive comparatorCapecitabine, Eribulin, Gemcitabine or Vinorelbine
Receives: Drug: Physician's-Choice

What is being measured

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

  1. Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment

    IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.

    Measured: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)

Secondary outcomes (8)

  1. Percentage of Participants With Objective Response: Investigator Assessment

    Investigator assessed objective response was defined as the percentage of participants with a partial response (PR) or complete response (CR) as defined by RECIST v1.1. For target lesions: 1) CR: disappearance of all non-nodal target lesions. Target lymph nodes must reduce to less than 10 mm in short axis. 2) PR: At least a 30% decrease in the sum of diameters of target lesions, compared to the sum at baseline. For non-target lesions, CR: disappearance of all non-target lesions. Percentage of participants with objective response reported are based upon unconfirmed CR/PR.

    Measured: Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)

  2. Overall Survival (OS)

    OS was defined as the time (in months) from randomization to death due to any cause. If death was not observed at the time of study cut-off date or permanently lost to follow-up, OS was censored at the date the participant was last known to be alive on or before the study cut-off date, whichever was earlier. The analysis was performed by Kaplan-Meier method.

    Measured: Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months

  3. Trough Plasma Talazoparib Concentrations

    A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.

    Measured: Predose on Day 1 of Cycle 2, 3 and 4

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse events (AE) was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug or the day before initiation of a new antineoplastic therapy or 30 days after the date of the last dose date of study drug, whichever occurred first, that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

    Measured: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

  5. Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology

    Toxicity grades were evaluated based on as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter [g/L]), leukocytes (10^6 cells per liter), lymphocytes (10^6 cells per liter), neutrophils (10^6 cells per liter), and platelets (10^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher values than the baseline values. Only those categories in which at least 1 participant had data were reported.

    Measured: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.

  6. Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry

    Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.

    Measured: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

  7. Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs

    Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (>=) 40 mmHg, 2) absolute results less than (<) 90 mmHg and decrease from baseline (DFB) >30 mmHg; b) Diastolic blood pressure: 1) absolute results >110 mmHg and >=30 mmHg increase from baseline, 2) absolute results <50 mmHg and >20 mmHg decrease from baseline 3) >=20 mmHg increase from baseline; c) Heart rate: 1) absolute results>120 beats per minute [bpm] and >30 bpm increase from baseline, 2) absolute results <50 bpm and >20 bpm decrease from baseline and d) Weight: >10 percent [%] decrease from baseline.

    Measured: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

  8. Number of Participants Taking At-least One Concomitant Medication

    Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.

    Measured: Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

Timeline

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

  1. First posted19 Sep 2013 (estimated)
  2. Study start14 Oct 2013
  3. Primary completion15 Sep 2017
  4. Study completion5 Mar 2021

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
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945775
Sponsor's protocol ID
673-301
Other IDs
C3441009, 2013-002716-28, U1111-1155-7579
Acronym
EMBRACA
Status last verified
Dec 2021
First submitted
11 Sep 2013
Last updated
20 Jan 2022
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Blum JL, Laird AD, Litton JK, Rugo HS, Ettl J, Hurvitz SA, Martin M, Roche HH, Lee KH, Goodwin A, Chen Y, Lanzalone S, Chelliserry J, Czibere A, Hopkins JF, Albacker LA, Mina LA. Determinants of Response to Talazoparib in Patients with HER2-Negative, Germline BRCA1/2-Mutated Breast Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1383-1390. doi: 10.1158/1078-0432.CCR-21-2080.

    PubMed 35091441

  • Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Goncalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. doi: 10.1093/annonc/mdy257.

    PubMed 30124753

  • Litton JK, Rugo HS, Ettl J, Hurvitz SA, Goncalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. doi: 10.1056/NEJMoa1802905. Epub 2018 Aug 15.

    PubMed 30110579

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing talazoparib and Physician's-Choice in people with Breast Neoplasms and BRCA 1 Gene Mutation, run by Pfizer at 362 sites in 16 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 7 inclusion and 19 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 362 sites in United States, Australia, Poland, Spain, Germany and 11 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 3 Oct 2018). 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?

Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment (time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 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 NCT01945775, which also lists 3 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 20 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in