AzTrials
AzTrials

Breast CancerPhase 3NCT01966471

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

A Phase 3 study testing Trastuzumab Emtansine, Trastuzumab and Pertuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 295 sites in 36 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

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab Emtansine, Trastuzumab and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,846 participants
Where
295 sitesin 36 countries
Study dates
31 Jan 2014to 4 Jun 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

  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
  • Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
  • HER2-positive breast cancer
  • Known hormone receptor status of the primary tumor
  • Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
  • Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:
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  • Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
  • Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive
  • No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
  • Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans
  • Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required
  • Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment

Who cannot join

  • History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
  • History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)
  • Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy
  • History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study
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  • Participants with contraindication to RT while adjuvant RT is clinically indicated
  • Concurrent anti-cancer treatment in another investigational trial
  • Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
  • Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
  • Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol
  • Chronic immunosuppressive therapies, including systemic corticosteroids

Trial locations and contacts

295 sites in 36 countries.

295 sites in 36 countries

United States50 sites

  • Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

    Annapolis, Maryland, 21401

  • University Cancer & Blood Center, LLC; Research

    Athens, Georgia, 30607

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Dana Farber Cancer Inst.

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • Wellmont Medical Associates

    Bristol, Virginia, 24201

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Health System; Hematology/Oncology Division

    Charlottesville, Virginia, 22908

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725

  • Karmanos Cancer Institute..

    Detroit, Michigan, 48201

  • Henry Ford Hospital; Hematology Oncology

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists; SCRI

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • West Clinic

    Germantown, Tennessee, 38138

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Indiana University

    Indianapolis, Indiana, 46202

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916-2305

  • ProHEALTH Care Associates LLP

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Med Center

    Lebanon, New Hampshire, 03756

  • Central Georgia Cancer Care PC

    Macon, Georgia, 31201

  • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Mercy Clinic Oklahoma Communties, Inc

    Oklahoma City, Oklahoma, 73120

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Quincy Medical Group; Canc Ctr at Blessing Hosp

    Quincy, Illinois, 62301

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298

  • Kaiser Permanente - Roseville; Oncology Pharmacy

    Roseville, California, 95661

  • Kaiser Permanente - Sacramento; Oncology Pharmacy

    Sacramento, California, 95814

  • UC Davis Cancer Center; Oncology

    Sacramento, California, 95817

  • US oncology research at Minnesota Oncology

    Saint Paul, Minnesota, 55102

  • Blue Ridge Cancer Care - Salem

    Salem, Virginia, 24153

  • Southern California Kaiser Permanente

    San Diego, California, 92108

  • Kaiser Permanente - San Jose

    San Jose, California, 95119

  • Kaiser Permanente - San Leandro

    San Leandro, California, 94577

  • HonorHealth Research Institute - Bisgrove

    Scottsdale, Arizona, 85258

  • University of Washington

    Seattle, Washington, 98195

  • Kaiser Permanente - South SF; Oncology Clinical trials

    South San Francisco, California, 94080

  • Mercy Medical Research Institute

    Springfield, Missouri, 65807

  • Florida Cancer Specialists; Saint Petersburg

    St. Petersburg, Florida, 33719

  • Stanford University School of Medicine

    Stanford, California, 94305-5151

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek; Oncology Pharmacy

    Walnut Creek, California, 94596

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

Other trials in United States

Japan32 sites

  • Aichi Cancer Center Hospital, Breast Oncology

    Aichi, 464-8681

  • Nagoya City University Hospital; Breast Surgery

    Aichi, 467-8602

  • Natl Hosp Org Shikoku; Cancer Ctr, Surgery

    Ehime, 791-0280

  • National Hospital Organization Kyushu Cancer Center;Breast Oncology

    Fukuoka, 811-1395

  • Gunma University Hospital; Department of Breast and Endocrine Surgery

    Gunma, 371-8511

  • Gunma Prefectural Cancer Center; Breast Oncology

    Gunma, 373-8550

  • Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

    Hiroshima, 730-8518

  • Hiroshima University Hospital; Breast Surgery

    Hiroshima, 734-8551

  • Hyogo College Of Medicine; Breast And Endocrine Surgery

    Hyōgo, 663-8501

  • Sagara Hospital; Breast Surgery

    Kagoshima, 892-0833

  • St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

    Kanagawa, 216-8511

  • Tokai University Hospital, Breast Surgery

    Kanagawa, 259-1193

  • Kumamoto City Hospital, Breast and Endocrine Surgery

    Kumamoto, 862-8505

  • Kumamoto Shinto General Hospital; Breast Cancer Center

    Kumamoto, 862-8655

  • Kyoto University Hospital; Breast Surgery

    Kyoto, 606-8507

  • Niigata Cancer Ctr Hospital; Breast Surgery

    Niigata, 951-8566

  • Iwate Med Univ School of Med; Surgery

    Numakunai, 028-3695

  • Kawasaki Medical School Hospital; Breast and Thyroid Surgery

    Okayama, 701-0114

  • Naha-nishi Clinic; Surgery

    Okinawa, 901-0154

  • National Hospital Organization Osaka National Hospital; Breast Surgery

    Osaka, 540-0006

  • Osaka International Cancer Institute; Breast and Endocrine Surgery

    Osaka, 541-8567

  • Saitama Medical University International Medical Center; Breast Oncology

    Saitama, 350-1298

  • Saitama Cancer Center, Breast Oncology

    Saitama, 362-0806

  • Shizuoka Cancer Center; Breast Surgery

    Shizuoka, 411-8777

  • Shizuoka General Hospital; Breast Surgery

    Shizuoka, 420-8527

  • Jichi Medical University; Breast Oncology

    Tochigi, 329-0498

  • National Cancer Center Hospital; Medical Oncology

    Tokyo, 104-0045

  • St. Luke's Internat. Hospital, Breast Surgical Oncology

    Tokyo, 104-8560

  • Tokyo Metropolitan; Komagome Hospital, Surgery

    Tokyo, 113-8677

  • The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

    Tokyo, 135-8550

  • Showa University Hospital; Breast Surgery

    Tokyo, 142-8666

  • Tokyo Medical Uni. Hospital; Breast Oncology

    Tokyo, 160-0023

Other trials in Japan

France24 sites

  • Ico - Paul Papin

    Angers, 49000

  • Clinique Sainte Catherine

    Avignon, 84082

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • CHU de Brest - Hôpital de Morvan

    Brest, 29609

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Centre Jean Perrin; Oncologie

    Clermont-Ferrand, 63011

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Clinique Victor Hugo; Chimiotherapie

    Le Mans, 72015

  • Centre Oscar Lambret; Cancerologie Gynecologique

    Lille, 59020

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Centre D'Oncologie de Gentilly; Oncology

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut de cancerologie du Gard

    Nîmes, 30029

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)

    Plérin, 22190

  • Polyclinique De Courlancy; Centre Radiotherapie Oncologie

    Reims, 51057

  • Centre Eugene Marquis; Service d'oncologie

    Rennes, 35042

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

    Saint-Priest-en-Jarez, 42271

  • Institut d'oncologie de l'Orangerie; Chimiotherapie

    Strasbourg, 67010

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Germany24 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Hochwaldkrankenhaus

    Bad Nauheim, 61231

  • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

    Berlin, 14169

  • Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

    Bochum, 44787

  • Praxis Dr.med. Katja Ziegler-Löhr

    Cologne, 50679

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307

  • AGAPLESION Markus-Krankenhaus

    Frankfurt, 60431

  • Städtische Kliniken Frankfurt am Main Höchst

    Frankfurt, 65929

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Dres.Jochen Wilke und Harald Wagner

    Fürth, 90766

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124

  • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik

    Hamburg, 20246

  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

    Hanover, 30177

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Klinikum Kulmbach; Frauenklinik

    Kulmbach, 95326

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

    Meiningen, 98617

  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

    München, 81377

  • Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum

    Ravensburg, 88212

  • Agaplesion Diakonieklinikum Rotenburg

    Rotenburg (Wümme), 27356

  • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

    Stralsund, 18439

  • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

    Troisdorf, 53840

  • GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

    Weinheim, 69469

  • Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

    Worms, 67550

Other trials in Germany

United Kingdom22 sites

  • Velindre Cancer Centre; Oncology Dept

    Cardiff, CF14 2TL

  • Cheltenham General Hospital; Gloucestershire Oncology Centre

    Cheltenham, GL53 7AN

  • Royal Cornwall Hospital; Dept of Clinical Oncology

    Cornwall, TR1 3LQ

  • University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre

    Coventry, CV2 2DX

  • Western General Hospital; Edinburgh Breast Unit

    Edinburgh, EH4 2XU

  • Royal Devon & Exeter Hospital; Oncology Centre

    Exeter, EX2 5DW

  • Royal Surrey County Hospital; St. Lukes Cancer Centre

    Guildford, GU2 7XX

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • Royal Marsden Hospital - Fulham; Oncology Department

    London, SW3 6JJ

  • Charing Cross Hospital

    London, W6 8RF

  • Maidstone Hospital; Kent Oncology Centre

    Maidstone, ME16 9QQ

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • Freeman Hospital; Northern Centre For Cancer Care

    New Castle Upon Tyne, NE7 7DN

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • Nottingham City Hospital; Oncology

    Nottingham, NG5 1PB

  • Peterborough City Hospital, Edith Cavell Campus; Oncology Department

    Peterborough, PE3 9GZ

  • Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B

    Portsmouth, PO6 3LY

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Musgrove Park Hospital; Department Clinical Research, Beacon Centre

    Somerset, TA1 5DA

  • Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

    Stoke-on-Trent, ST4 6QG

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

  • Yeovil District Hospital; Macmillan Cancer Unit

    Yeovil, BA21 4AT

Other trials in United Kingdom

Canada18 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec, H7M 3L9

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • Regional health authority A vitalite health network

    Moncton, New Brunswick, E1C 8X3

  • McGill University; Glen Site; Oncology

    Montreal, Quebec, H4A 3J1

  • Southlake Regional Health Center; Community Care Clinic / Oncology

    Newmarket, Ontario, L3Y 2P9

  • Lions Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

  • North York General Hospital

    Toronto, Ontario, M2J 1V1

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Italy15 sites

  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

    Aviano, Friuli Venezia Giulia, 33081

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • Ospedale Antonio Perrino; Oncologia Medica

    Brindisi, Apulia, 72100

  • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

    Cremona, Lombardy, 26100

  • Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

    Milan, Lombardy, 20133

  • Humanitas Centro Catanese Di Oncologia; Oncologia Medica

    Misterbianco (CT), Sicily, 95045

  • ASST DI MONZA; Oncologia Medica

    Monza, Lombardy, 20900

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

    Padova, Veneto, 35128

  • Ospedale Misericordia E Dolce; Oncologia Medica

    Prato, Tuscany, 59100

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Rome, Lazio, 00144

  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera S. Maria - Terni; Oncologia

    Terni, Umbria, 05100

Other trials in Italy

Spain11 sites

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

    Madrid, 28033

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

    Murcia, 30120

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

Australia8 sites

  • Burnside War Memorial Hospital, Clinical Trials Centre

    Adelaide, South Australia, 5056

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Frankston Hospital; Oncology/Haematology

    Frankston, Victoria, 3199

  • Austin Hospital; Medical Oncology

    Heidelberg, Victoria, 3084

  • St John of God Murdoch Hospital; Oncology West

    Murdoch, Western Australia, 6150

  • Epworth HealthCare; Clinical Trials Centre

    Richmond, Victoria, 3121

  • Haematology & Oncology Clinics of Australia Research Centre

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

Brazil8 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiânia, Goiás, 74605-070

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Sirio Libanes; Centro de Oncologia

    São Paulo, São Paulo, 01308-050

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

  • Hospital Paulistano

    São Paulo, São Paulo, 01321-000

Other trials in Brazil

Poland8 sites

  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

    Bialystok, 15-027

  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii

    Lodz, 93-513

  • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

    Lublin, 20-090

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

    Warsaw, 02-781

Other trials in Poland

Russia7 sites

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

    Kazan', 420029

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, 115478

  • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

    Orenburg, 460021

  • SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

    Ryazan, 390011

  • Scientific Research Institute n.a. N.N. Petrov

    Saint Petersburg, 197758

  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary

    Samara, 443031

Other trials in Russia

Taiwan6 sites

  • Changhua Christian Hospital; Dept of Surgery

    Changhua, 500

  • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

    Kaohsiung City, 807

  • Taichung Veterans General Hospital; Dept of Surgery

    Taichung, 407

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

  • Tri-Service General Hospital, Division of General Surgery

    Taipei, 114

Other trials in Taiwan

South Korea5 sites

  • National Cancer Center; Medical Oncology

    Gyeonggi-do, 410-769

  • Ajou Uni Hospital; Medical Oncology

    Gyeonggi-do, 443-380

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Centre; Division of Hematology/Oncology

    Seoul, 135-710

Other trials in South Korea

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

    Hradec Králové, 500 05

  • MULTISCAN, s.r.o., Radiologicke centrum Pardubice

    Pardubice, 532 03

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Hungary4 sites

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

    Budapest, 1145

  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

    Debrecen, 4032

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

Other trials in Hungary

Mexico4 sites

  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

    Distrito Federal, 14000

  • Fundacion Rodolfo Padilla Padilla A.C.

    León, 37000

  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

    Mexico City, 03100

  • Hospital San Jose Del Tec. de Monterrey; Oncology

    Monterrey, 64020

Other trials in Mexico

Peru4 sites

  • Clinica de Especialidades Medicas

    Lima, Lima 41

  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

    Lima, Lima 41

  • Clinica San Borja

    Lima, Lima 41

  • Instituto Oncologico Miraflore

    Miraflores, Lima 18

Other trials in Peru

Romania4 sites

  • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

    Bucharest, 022328

  • Cluj Clinical County Hospital; Oncology Dept

    Cluj-Napoca, 400006

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Regional Institute of Oncology Iasi

    Iași, 700483

Other trials in Romania

Thailand4 sites

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Chiang Rai Prachanukroh Hospital; Department Of Medicine

    Chiang Rai, 57000

  • Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine

    Phitsanuok, 65000

Other trials in Thailand

Georgia3 sites

  • LTD Institute of Clinical Oncology

    Tbilisi, 0159

  • Khechinashvili University Hospital ;Breast Unit

    Tbilisi, 0177

  • Chemotherapy and Immunotherapy Clinic Medulla

    Tbilisi, 0186

Other trials in Georgia

Hong Kong3 sites

  • Princess Margaret Hospital; Oncology

    Hong Kong

  • Tuen Mun Hospital; Clinical Oncology

    Hong Kong

  • Queen Mary Hospital; Dept of Surgery

    Pokfulam

Other trials in Hong Kong

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset; Jubileumskliniken

    Gothenburg, 413 45

  • Universitetssjukhuset Örebro, Onkologiska kliniken

    Örebro, 701 85

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85

Other trials in Sweden

Switzerland3 sites

  • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

    Chur, 7000

  • Luzerner Kantonsspital; Medizinische Onkologie

    Lucerne, 6004

  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

    Zurich, 8008

Other trials in Switzerland

Belgium2 sites

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Sint Augustinus Wilrijk, Apotheek

    Wilrijk, 2610

Other trials in Belgium

Bosnia and Herzegovina2 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100

Other trials in Bosnia and Herzegovina

Chile2 sites

  • Instituto Oncologico del sur

    Temuco, 4810469

  • ONCOCENTRO APYS; Oncología

    Viña del Mar, 2520598

Other trials in Chile

Guatemala2 sites

  • Centro Oncológico Sixtino / Centro Oncológico SA

    Guatemala City, 01010

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Israel2 sites

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

  • Sourasky / Ichilov Hospital; Oncology Department

    Tel Aviv, 64239-06

Other trials in Israel

Norway2 sites

  • Oslo universitetssykehus HF, Ullevål, Kreftsenteret

    Oslo, 0450

  • Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

    Stavanger, 4011

Other trials in Norway

Philippines2 sites

  • San Juan de Dios Hospital;Oncology Unit

    Pasay, 1300

  • East Avenue Medical Center

    Quezon City, 1100

Other trials in Philippines

Singapore2 sites

  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    Singapore, 119228

  • National Cancer Centre; Medical Oncology

    Singapore, 169610

Other trials in Singapore

Ukraine2 sites

  • State Medical Academy; Oncology

    Dnipropetrovsk, 43102

  • Lviv State Oncological Regional Treatment and Diagnostic Center

    Lviv, 79031

Other trials in Ukraine

Colombia1 site

  • Oncomedica S.A.

    Montería, 230002

Other trials in Colombia

El Salvador1 site

  • Hospital Diagnostico Escalón

    San Salvador, 01101

Other trials in El Salvador

Panama1 site

  • Centro Hemato Oncologico Panama

    Panama City, 0832

Other trials in Panama

About this study

Official title: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

Conditions
Breast Cancer
Being tested
Trastuzumab Emtansine, Trastuzumab, Pertuzumab, Paclitaxel, Epirubicin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Trastuzumab EmtansineDrug

    Also called Kadcyla

    Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).

  • PertuzumabDrug

    Also called Perjeta

    Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).

  • PaclitaxelDrug

    IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.

  • EpirubicinDrug

    3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

  • DoxorubicinDrug

    3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

  • DocetaxelDrug

    IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter [mg/m^2] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m^2 in the first cycle and escalate to 100 mg/m^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.

  • CyclophosphamideDrug

    3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

  • 5-FluorouracilDrug

    3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Study groups in NCT01966471
Study groupRoleWhat they receive
Anthracycline Followed by Trastuzumab, Pertuzumab, and TaxaneActive comparatorTrastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Paclitaxel; Drug: Epirubicin; Drug: Doxorubicin; Drug: Docetaxel; Drug: Cyclophosphamide; Drug: 5-Fluorouracil
Anthracycline Followed by Trastuzumab Emtansine and PertuzumabExperimentalTrastuzumab emtansine and pertuzumab will continue for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
Receives: Drug: Trastuzumab Emtansine; Drug: Epirubicin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: 5-Fluorouracil

What is being measured

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

  1. Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation

    IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.

    Measured: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.

  2. Invasive Disease-Free Survival (IDFS) in the Overall Population

    IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer [bc] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site [other than the three sites mentioned above]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.

    Measured: First participant randomized up to approximately 7.5 years

Secondary outcomes (9)

  1. IDFS Plus Second Primary Non-Breast Cancer

    IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site).

    Measured: Baseline up to approximately 70 months

  2. Disease-Free Survival (DFS)

    DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS).

    Measured: Baseline up to approximately 70 months

  3. Distant Recurrence-Free Interval (DRFI)

    DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence.

    Measured: Baseline up to approximately 70 months

  4. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: First participant randomized up to approximately 7.5 years

  5. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0).

    Measured: From randomization to approximately 7.5 years

  6. Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time

    LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.

    Measured: First participant randomized up to approximately 7.5 years.

  7. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score

    The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).

    Measured: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18

  8. EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score

    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement.

    Measured: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18

  9. Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment

    The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning.

    Measured: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.

Timeline

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

  1. First posted21 Oct 2013 (estimated)
  2. Study start31 Jan 2014
  3. Primary completion27 Nov 2019
  4. Study completion4 Jun 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
1,846 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966471
Sponsor's protocol ID
BO28407
Other IDs
2012-004902-82
Status last verified
Jun 2022
First submitted
17 Oct 2013
Last updated
14 Jun 2022

Publications

  • Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol. 2022 Feb 10;40(5):438-448. doi: 10.1200/JCO.21.00896. Epub 2021 Dec 10.

    PubMed 34890214

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Emtansine, Trastuzumab and Pertuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 295 sites in 36 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 12 inclusion and 15 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 295 sites in United States, Japan, France, Germany, United Kingdom and 31 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 12 Jan 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?

Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation (time frame: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.). The study lists 2 primary outcomes in all. 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 NCT01966471, which also lists 1 linked publication.

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 14 Jun 2022.

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