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

June 13, 2022 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1846

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle; Medical Oncology
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Haematology & Oncology Clinics of Australia Research Centre
    • South Australia
      • Adelaide, South Australia, Australia, 5056
        • Burnside War Memorial Hospital, Clinical Trials Centre
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital; Oncology/Haematology
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital; Medical Oncology
      • Richmond, Victoria, Australia, 3121
        • Epworth HealthCare; Clinical Trials Centre
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St John of God Murdoch Hospital; Oncology West
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk, Apotheek
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • University Clinical Center of the Republic of Srpska
      • Sarajevo, Bosnia and Herzegovina, 7100
        • Clinic of Oncology, University Clinical Center Sarajevo
  • Brazil
    • GO
      • Goiania, GO, Brazil, 74605-070
        • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora Da Conceicao
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Sao Paulo, SP, Brazil, 01308-050
        • Hospital Sirio Libanes; Centro de Oncologia
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
      • Sao Paulo, SP, Brazil, 01321-000
        • Hospital Paulistano
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Regional health authority A vitalite health network
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre; Oncology
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Center; Community Care Clinic / Oncology
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa; Oncology
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Sault Area Hospital
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
      • Toronto, Ontario, Canada, M2J 1V1
        • North York General Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Cite de La Sante de Laval; Hemato-Oncologie
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University; Glen Site; Oncology
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
  • Chile
      • Temuco, Chile, 4810469
        • Instituto Oncologico del Sur
      • Vina Del Mar, Chile, 2520598
        • ONCOCENTRO APYS; Oncología
  • Colombia
      • Monteria, Colombia, 230002
        • Oncomedica S.A.
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Hradec Kralove, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
      • Pardubice, Czechia, 532 03
        • MULTISCAN, s.r.o., Radiologicke centrum Pardubice
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • El Salvador
      • San Salvador, El Salvador, 01101
        • Hospital Diagnostico Escalón
  • France
      • Angers, France, 49000
        • ICO - Paul Papin
      • Avignon, France, 84082
        • Clinique Sainte Catherine
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33076
        • Institut Bergonie; Oncologie
      • Brest, France, 29609
        • CHU de Brest - Hôpital de Morvan
      • Caen, France, 14076
        • Centre Francois Baclesse; Oncologie
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin; Oncologie
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Le Mans, France, 72015
        • Clinique Victor Hugo; Chimiotherapie
      • Lille, France, 59020
        • Centre Oscar Lambret; Cancerologie Gynecologique
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nimes, France, 30029
        • Institut de cancerologie du Gard
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Plerin, France, 22190
        • Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)
      • Reims, France, 51057
        • Polyclinique De Courlancy; Centre Radiotherapie Oncologie
      • Rennes, France, 35042
        • Centre Eugene Marquis; Service d'oncologie
      • Saint Herblain, France, 44805
        • Ico Rene Gauducheau; Oncologie
      • St Priest En Jarez, France, 42271
        • Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Strasbourg, France, 67010
        • Institut d'oncologie de l'Orangerie; Chimiotherapie
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • Vandoeuvre-les-nancy, France, 54519
        • Centre Alexis Vautrin; Oncologie Medicale
  • Georgia
      • Tbilisi, Georgia, 0159
        • LTD Institute of Clinical Oncology
      • Tbilisi, Georgia, 0177
        • Khechinashvili University Hospital ;Breast Unit
      • Tbilisi, Georgia, 0186
        • Chemotherapy and Immunotherapy Clinic Medulla
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Bad Nauheim, Germany, 61231
        • Hochwaldkrankenhaus
      • Berlin, Germany, 14169
        • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
      • Bochum, Germany, 44787
        • Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
      • Dresden, Germany, 01307
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
      • Frankfurt, Germany, 60431
        • AGAPLESION Markus-Krankenhaus
      • Frankfurt, Germany, 65929
        • Städtische Kliniken Frankfurt am Main Höchst
      • Freiburg, Germany, 79110
        • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
      • Fürth, Germany, 90766
        • Dres.Jochen Wilke und Harald Wagner
      • Georgsmarienhütte, Germany, 49124
        • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
      • Hannover, Germany, 30177
        • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
      • Kulmbach, Germany, 95326
        • Klinikum Kulmbach; Frauenklinik
      • Köln, Germany, 50679
        • Praxis Dr.med. Katja Ziegler-Löhr
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
      • Meiningen, Germany, 98617
        • Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
      • Muenchen, Germany, 81377
        • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
      • Ravensburg, Germany, 88212
        • Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
      • Rotenburg/Wümme, Germany, 27356
        • Agaplesion Diakonieklinikum Rotenburg
      • Stralsund, Germany, 18439
        • Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
      • Troisdorf, Germany, 53840
        • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
      • Weinheim, Germany, 69469
        • GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
      • Worms, Germany, 67550
        • Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Centro Oncológico Sixtino / Centro Oncológico SA
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital; Oncology
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital; Clinical Oncology
      • Pokfulam, Hong Kong
        • Queen Mary Hospital; Dept of Surgery
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
      • Budapest, Hungary, 1145
        • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Israel
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center; Oncology Dept
      • Tel Aviv, Israel, 64239-06
        • Sourasky / Ichilov Hospital; Oncology Department
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
      • Roma, Lazio, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena Irccs
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
        • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
      • Monza, Lombardia, Italy, 20900
        • ASST DI MONZA; Oncologia Medica
      • Rozzano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
    • Sicilia
      • Misterbianco (CT), Sicilia, Italy, 95045
        • Humanitas Centro Catanese Di Oncologia; Oncologia Medica
    • Toscana
      • Prato, Toscana, Italy, 59100
        • Ospedale Misericordia E Dolce; Oncologia Medica
    • Umbria
      • Terni, Umbria, Italy, 05100
        • Azienda Ospedaliera S. Maria - Terni; Oncologia
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital, Breast Oncology
      • Aichi, Japan, 467-8602
        • Nagoya City University Hospital; Breast Surgery
      • Ehime, Japan, 791-0280
        • Natl Hosp Org Shikoku; Cancer Ctr, Surgery
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center;Breast Oncology
      • Gunma, Japan, 371-8511
        • Gunma University Hospital; Department of Breast and Endocrine Surgery
      • Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center; Breast Oncology
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital; Breast Surgery
      • Hyogo, Japan, 663-8501
        • Hyogo College Of Medicine; Breast And Endocrine Surgery
      • Iwate, Japan, 028-3695
        • Iwate Med Univ School of Med; Surgery
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital; Breast Surgery
      • Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital, Breast Surgery
      • Kumamoto, Japan, 862-8505
        • Kumamoto City Hospital, Breast and Endocrine Surgery
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital; Breast Cancer Center
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital; Breast Surgery
      • Niigata, Japan, 951-8566
        • Niigata Cancer Ctr Hospital; Breast Surgery
      • Okayama, Japan, 701-0114
        • Kawasaki Medical School Hospital; Breast and Thyroid Surgery
      • Okinawa, Japan, 901-0154
        • Naha-nishi Clinic; Surgery
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital; Breast Surgery
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute; Breast and Endocrine Surgery
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center; Breast Oncology
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center, Breast Oncology
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center; Breast Surgery
      • Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital; Breast Surgery
      • Tochigi, Japan, 329-0498
        • Jichi Medical University; Breast Oncology
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital; Medical Oncology
      • Tokyo, Japan, 104-8560
        • St. Luke's Internat. Hospital, Breast Surgical Oncology
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan; Komagome Hospital, Surgery
      • Tokyo, Japan, 135-8550
        • The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
      • Tokyo, Japan, 142-8666
        • Showa University Hospital; Breast Surgery
      • Tokyo, Japan, 160-0023
        • Tokyo Medical Uni. Hospital; Breast Oncology
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center; Medical Oncology
      • Gyeonggi-do, Korea, Republic of, 443-380
        • Ajou Uni Hospital; Medical Oncology
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03080
        • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Centre; Division of Hematology/Oncology
  • Mexico
      • Distrito Federal, Mexico, 14000
        • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
      • León, Mexico, 37000
        • Fundacion Rodolfo Padilla Padilla A.C.
      • Mexico City, Mexico, 03100
        • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
      • Monterrey, Mexico, 64020
        • Hospital San Jose Del Tec. de Monterrey; Oncology
  • Norway
      • Oslo, Norway, 0450
        • Oslo universitetssykehus HF, Ullevål, Kreftsenteret
      • Stavanger, Norway, 4011
        • Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
  • Panama
      • Panama, Panama, 0832
        • Centro Hemato Oncologico Panama
  • Peru
      • Lima, Peru, Lima 41
        • Clinica de Especialidades Medicas
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
      • Lima, Peru, Lima 41
        • Clinica San Borja
      • Miraflores, Peru, Lima 18
        • Instituto Oncologico Miraflore
  • Philippines
      • Pasay, Philippines, 1300
        • San Juan de Dios Hospital;Oncology Unit
      • Quezon City, Philippines, 1100
        • East Avenue Medical Center
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Kraków, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
      • Warszawa, Poland, 02-781
        • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
  • Romania
      • Bucuresti, Romania, 022328
        • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Cluj-Napoca, Romania, 400006
        • Cluj Clinical County Hospital; Oncology Dept
      • Iasi, Romania, 700483
        • Regional Institute of Oncology Iasi
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
      • Moscow, Russian Federation, 115478
        • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
      • Orenburg, Russian Federation, 460021
        • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
      • Ryazan, Russian Federation, 390011
        • SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
      • Saint Petersburg, Russian Federation, 197758
        • Scientific Research Institute n.a. N.N. Petrov
      • Samara, Russian Federation, 443031
        • SBI of Healthcare Samara Regional Clinical Oncology Dispensary
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital; National University Cancer Institute, Singapore (NCIS)
      • Singapore, Singapore, 169610
        • National Cancer Centre; Medical Oncology
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar; Servicio de Oncologia
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
      • Barcelona, Spain, 08907
        • Hospital Duran i Reynals; Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 28033
        • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia; Servicio de Oncología
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Oncologia
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias;servicio de Oncologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Oncologia
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset; Jubileumskliniken
      • Uppsala, Sweden, 751 85
        • Akademiska sjukhuset, Onkologkliniken
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Örebro, Onkologiska kliniken
  • Switzerland
      • Chur, Switzerland, 7000
        • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
      • Luzern, Switzerland, 6004
        • Luzerner Kantonsspital; Medizinische Onkologie
      • Zürich, Switzerland, 8008
        • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital; Dept of Surgery
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Dept of Surgery
      • Taipei, Taiwan, 00112
        • VETERANS GENERAL HOSPITAL; Department of General Surgery
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; General Surgery
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital, Division of General Surgery
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital; Medical Oncology
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
      • Chiang Rai, Thailand, 57000
        • Chiang Rai Prachanukroh Hospital; Department Of Medicine
      • Phitsanuok, Thailand, 65000
        • Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
  • Ukraine
      • Dnipropetrovsk, Ukraine, 43102
        • State Medical Academy; Oncology
      • Lviv, Ukraine, 79031
        • Lviv State Oncological Regional Treatment and Diagnostic Center
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre; Oncology Dept
      • Cheltenham, United Kingdom, GL53 7AN
        • Cheltenham General Hospital; Gloucestershire Oncology Centre
      • Cornwall, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital; Dept of Clinical Oncology
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital; Edinburgh Breast Unit
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon & Exeter Hospital; Oncology Centre
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital; St. Lukes Cancer Centre
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary; Dept. of Medical Oncology
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - Fulham; Oncology Department
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone Hospital; Kent Oncology Centre
      • Manchester, United Kingdom, M20 4QL
        • Christie Hospital; Breast Cancer Research Office
      • New Castle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital; Northern Centre For Cancer Care
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital; Oncology
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital, Edith Cavell Campus; Oncology Department
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital; Cancer Clinical Trials Centre
      • Somerset, United Kingdom, TA1 5DA
        • Musgrove Park Hospital; Department Clinical Research, Beacon Centre
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Dept of Medical Oncology
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital; Macmillan Cancer Unit
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute - Bisgrove
    • California
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland
      • Roseville, California, United States, 95661
        • Kaiser Permanente - Roseville; Oncology Pharmacy
      • Sacramento, California, United States, 95814
        • Kaiser Permanente - Sacramento; Oncology Pharmacy
      • Sacramento, California, United States, 95817
        • UC Davis Cancer Center; Oncology
      • San Diego, California, United States, 92108
        • Southern California Kaiser Permanente
      • San Jose, California, United States, 95119
        • Kaiser Permanente - San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente - San Leandro
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente - South SF; Oncology Clinical trials
      • Stanford, California, United States, 94305-5151
        • Stanford University School of Medicine
      • Vallejo, California, United States, 94589
        • Kaiser Permanente - Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente - Walnut Creek; Oncology Pharmacy
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists; SCRI
      • Saint Petersburg, Florida, United States, 33719
        • Florida Cancer Specialists; Saint Petersburg
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC; Research
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care PC
    • Illinois
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group; Canc Ctr at Blessing Hosp
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Inst.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute..
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital; Hematology Oncology
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • US oncology research at Minnesota Oncology
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Mercy Medical Research Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Med Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center
      • Lake Success, New York, United States, 11042
        • ProHEALTH Care Associates LLP
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Clinic Oklahoma Communties, Inc
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Woman's Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • SCRI Tennessee Oncology Chattanooga
      • Germantown, Tennessee, United States, 38138
        • West Clinic
      • Knoxville, Tennessee, United States, 37916-2305
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders - Fort Worth
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Wellmont Medical Associates
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System; Hematology/Oncology Division
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University - Massey Cancer Center
      • Salem, Virginia, United States, 24153
        • Blue Ridge Cancer Care - Salem
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane
Trastuzumab 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.
Drug: Trastuzumab
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).
Other Names:
  • Herceptin
Drug: Pertuzumab
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).
Other Names:
  • Perjeta
Drug: Paclitaxel
IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
Drug: Epirubicin
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.
Drug: Doxorubicin
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.
Drug: Docetaxel
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.
Drug: Cyclophosphamide
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.
Drug: 5-Fluorouracil
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.
Experimental: Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab
Trastuzumab 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.
Drug: Epirubicin
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.
Drug: Doxorubicin
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.
Drug: Cyclophosphamide
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.
Drug: 5-Fluorouracil
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.
Drug: Trastuzumab Emtansine
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).
Other Names:
  • Kadcyla

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Invasive Disease-Free Survival (IDFS) in the Overall Population
Time Frame: First participant randomized up to approximately 7.5 years
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.
First participant randomized up to approximately 7.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDFS Plus Second Primary Non-Breast Cancer
Time Frame: Baseline up to approximately 70 months
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).
Baseline up to approximately 70 months
Disease-Free Survival (DFS)
Time Frame: Baseline up to approximately 70 months
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).
Baseline up to approximately 70 months
Distant Recurrence-Free Interval (DRFI)
Time Frame: Baseline up to approximately 70 months
DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence.
Baseline up to approximately 70 months
Overall Survival (OS)
Time Frame: First participant randomized up to approximately 7.5 years
OS was defined as the time from randomization to death due to any cause.
First participant randomized up to approximately 7.5 years
Percentage of Participants With Adverse Events
Time Frame: From randomization to approximately 7.5 years
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).
From randomization to approximately 7.5 years
Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
Time Frame: First participant randomized up to approximately 7.5 years.
LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
First participant randomized up to approximately 7.5 years.
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
Time Frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
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).
Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
Time Frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
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.
Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
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
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2014

Primary Completion (Actual)

November 27, 2019

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO28407
  • 2012-004902-82 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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