Breast CancerPhase 3APHINITYNCT01358877
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
A Phase 3 study testing 5-Fluorouracil, Carboplatin and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 546 sites in 42 countries.
Trial summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. 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?
- 5-Fluorouracil, Carboplatin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,804 participants
- Where
- 546 sitesin 42 countries
- Study dates
- 8 Nov 2011to 28 Nov 2024
- Phase
- Phase 3
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
- Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
- Known hormone receptor status (estrogen receptor and progesterone receptor)
- The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
- Confirmed HER2 positive status
- Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
- Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
Who cannot join
- History of any prior (ipsi- and/or contralateral) invasive breast cancer
- History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
- Any node-negative tumor
- Any previous systemic chemotherapy for cancer or radiotherapy for cancer
- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
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- Concurrent anti-cancer treatment in another investigational trial
- Serious cardiac or cardiovascular disease or condition
- Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
- Abnormal laboratory tests immediately prior to randomization
- Pregnant or lactating women
- Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Trial locations and contacts
546 sites in 42 countries.
546 sites in 42 countries
United States114 sites
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
New York Oncology Hematology, P.C.
Albany, New York, 12206
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Mercy Medical Center
Baltimore, Maryland, 21202
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, 21237
Cancer Care of Maine
Bangor, Maine, 04401
Maryland Oncology & Hematology, PA
Bethesda, Maryland, 20817
Massachusetts General Hospital.
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deac Med Ctr
Boston, Massachusetts, 02215
Dana Farber Can Ins
Boston, Massachusetts, 02215
Wellmonth Physician Services
Bristol, Virginia, 24201
Roswell Park Cancer Inst.
Buffalo, New York, 14263
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
Charleston Oncology, P .A
Charleston, South Carolina, 29414
Roper Bon Secours St. Francis Cancer Center
Charleston, South Carolina, 29414
Tennessee Oncology , PLLC - Chattanooga
Chattanooga, Tennessee, 37403
Rush University Medical Center
Chicago, Illinois, 60612
Uni of Chicago
Chicago, Illinois, 60637
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210
University of Missouri-Columbia
Columbia, South Carolina, 65203
The Mark H. Zangmeister Ctr
Columbus, Ohio, 43219
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230
Texas Oncology - DFW at Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology - DFW
Dallas, Texas, 75246
Dayton Clinical Oncology Prog
Dayton, Ohio, 45420
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220
Southdale Cancer Clinic
Edina, Minnesota, 55414
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas, 79902
Providence Regional Medical Center
Everett, California, 98208
Florida Cancer Specialists
Fort Myers, Florida, 33916
Texas Oncology - DFW Fort Worth
Fort Worth, Texas, 76104
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104
Texas Oncology, P.A. - Garland
Garland, Texas, 77060
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Green Bay Oncology/St. Mary?s Hospital
Green Bay, Wisconsin, 54301
Marin Cancer Care Inc
Greenbrae, California, 94904
Cancer Centers of the Carolina
Greenville, South Carolina, 29615
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Kaiser Permanente - Hayward
Hayward, California, 94545
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602
Memorial Cancer Institute
Hollywood, Florida, 33021
Texas Oncology - Houston (Gessner)
Houston, Texas, 77024
University of Iowa
Iowa City, Iowa, 52242
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224
Cancer Specialists
Jacksonville, Florida, 32256
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
UCSD Moores Cancer Center
La Jolla, California, 92093
Cancer Center of Acadiana at Lafayette General
Lafayette, Louisiana, 70503
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, 03756
Cancer Alliance of Nebraska
Lincoln, Nebraska, 68510
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
Marshfield Clinic
Marshfield, Wisconsin, 54449
Loyola University Med Center
Maywood, Illinois, 60153
West Virginia University Hospitals Inc
Morgantown, West Virginia, 26506-9162
Edward Cancer Center Naperville
Naperville, Illinois, 60540
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
Cancer Care Centers of South Texas-HOAST - San Antonio
New Braunfels, Texas, 78130
Mount Sinai Beth Israel Medical Center
New York, New York, 10003
Mount Sinai Beth Israel Comprehensive Cancer Center
New York, New York, 10011
Mount Sinai West
New York, New York, 10019
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Eastern Ct Hema/Onco Assoc
Norwich, Connecticut, 06360
Kaiser Permanente - Oakland
Oakland, California, 94611
Ocala Oncology Center
Ocala, Florida, 34474
Community Cancer Trials of Utah
Ogden, Utah, 84405
Cancer Alliance of Nebraska
Omaha, Nebraska, 68106
Memorial Breast Cancer Center
Pembroke Pines, Florida, 33028
Illinois Cancer Care
Peoria, Illinois, 61615-7828
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Berkshire Hematology, Oncology Pc
Pittsfield, Massachusetts, 01201
Edward Cancer Center Plainfield
Plainfield, Illinois, 60585
Texas Oncology - DFW Plano
Plano, Texas, 75075
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Northwest Cancer Specialists - Portland (NE Hoyt St)
Portland, Oregon, 97213
Kootenai Cancer Center
Post Falls, Idaho, 83854
Quincy Medical Group
Quincy, Illinois, 62301
Virginia Cancer Institute
Richmond, Virginia, 23230
Kaiser Permanente - Roseville
Roseville, California, 95661
Sutter Cancer Center
Sacramento, California, 95816
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
Coborn Cancer Center
Saint Cloud, Minnesota, 56303
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
Southern California Kaiser Permanente
San Diego, California, 92108
K. Permanente - San Fransisco
San Francisco, California, 94115
K. Permanente - San Jose
San Jose, California, 95119
K. Permanente - Santa Clara
Santa Clara, California, 95051
New England Cancer Specialists
Scarborough, Maine, 04074
HonorHealth Research Institute ? Bisgrove
Scottsdale, Arizona, 85258
Sanford USD School of Medicine
Sioux Falls, South Dakota, 57104
K. Permanente - S. San Fran
South San Francisco, California, 94080
Washington University School of Medicine
St Louis, Missouri, 63110
Heartland CCOP/Missouri Baptist Medical Center
St Louis, Missouri, 63131
Florida Cancer Specialists
St. Petersburg, Florida, 33705
SUNY Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10467
Toledo Clinic Cancer Center
Toledo, Ohio, 43623-3536
Texas Oncology-Tyler
Tyler, Texas, 75702
Carle Foundation
Urbana, Illinois, 61801
Kaiser Permanente
Vallejo, California, 94589
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, 99362
K. Permanente - Walnut Creek
Walnut Creek, California, 94596
Washington Cancer Institute at MedStar Washington Hospital Center.
Washington D.C., District of Columbia, 20010
Georgetown U
Washington D.C., District of Columbia, 20057
Florida Cancer Specialists, Research Department
West Palm Beach, Florida, 33401
Lutheran Hematology &Oncology
Wheat Ridge, Colorado, 80033
Cancer Center of Kansas
Wichita, Kansas, 67214-3728
Germany65 sites
Gesundheitszentrum St. Marien GmbH
Amberg, 92224
Hochwaldkrankenhaus
Bad Nauheim, 61231
Praxis Dr. Schoenegg
Berlin, 10719
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, 14169
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, 33604
Klinikum Sindelfingen-Böblingen
Böblingen, 71032
Universitätsklinikum Bonn
Bonn, 53127
Praxis Dr. Ralf Lorenz
Braunschweig, 38100
Hämato-Onkologie im Medicum/Home
Bremen, 28209
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe
Cologne, 50931
St. Elisabeth Krankenhaus Köln GmbH
Cologne, 50935
DONAU ISAR Klinikum Deggendorf
Deggendorf, 94469
St. Johannes-Hospital
Dortmund, 44137
Universitätsklinikum "Carl Gustav Carus"
Dresden, 01307
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
Düsseldorf, 40235
Praxis für Hamatologie und Onkologie
Erfurt, 99085
Universitätsklinikum Erlangen
Erlangen, 91054
Klinikum Esslingen
Esslingen am Neckar, 73730
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, 60596
Städtische Kliniken Frankfurt am Main Höchst
Frankfurt, 65929
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, 60389
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110
Dres.Jochen Wilke und Harald Wagner
Fürth, 90766
Universitätsklinikum Greifswald
Greifswald, 17475
Universitätsklinikum Halle (Saale)
Halle, 06120
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
SANA Klinikum Hameln-Pyrmont
Hamelin, 31785
Diakovere Henriettenstift, Frauenklinik
Hanover, 30171
MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
Hanover, 30177
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Praxisgemeinschaft
Hildesheim, 31134
Universitätsklinikum des Saarlandes
Homburg/Saar, 66424
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, 76135
Elisabeth-Krankenhaus Brustzentrum
Kassel, 34117
Klinikum Kassel GmbH
Kassel, 34125
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, 24105
Klinikum Landshut Frauenklinik
Landshut, 84034
Sankt Elisabeth Krankenhaus
Leipzig, 04277
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Lichtenberg, 10367
Universitätsklinikum Schleswig-Holstein / Campus Lübeck
Lübeck, 23562
Evangelisches Krankenhaus
Ludwigsfelde, 14974
Universitätsmedizin Mainz
Mainz, 55131
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, 41061
Klinikum der Universität München
München, 80336
Rotkreuzklinikum München
München, 80637
Klinikum rechts der Isar der TU München
München, 81675
Universitätsklinikum Münster
Münster, 48149
Sana Klinikum Offenbach GmbH
Offenbach, 63069
Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
Oldenburg, 26133
Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
Ravensburg, 88212
Oncologianova GmbH
Recklinghausen, 45657
RoMed Klinikum Rosenheim
Rosenheim, 83022
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
Rostock, 18059
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -
Stade, 21680
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Trier, 54290
Universitätsklinik Tübingen
Tübingen, 72076
Universitätsklinikum Ulm Am Michelsberg
Ulm, 89075
Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
Velbert, 42551
Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
Villingen-Schwenningen, 78052
St. Josefs-Hospital Wiesbaden
Wiesbaden, 65189
Marien-Hospital Witten
Witten, 58452
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg, 97080
France40 sites
Clinique De L Europe
Amiens, 80090
ICO Paul Papin
Angers, 49000
HOP Prive Arras Les Bonnettes
Arras, 62012
Institut Sainte Catherine
Avignon, 84000
ICONE
Bezannes, 51430
Institut Bergonie
Bordeaux, 33076
Polyclinique Bordeaux Nord
Bordeaux, 33300
Hopital Augustin Morvan
Brest, 29200
Centre Francois Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Leonard De Vinci
Dechy, 59187
Centre Georges-François Lecler
Dijon, 21034
Institut Daniel Hollard
Grenoble, 38000
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925
Clinique des Ormeaux
Le Havre, 76600
Centre Oscar Lambret
Lille, 59020
Hopital Dupuytren
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Institut Paoli Calmettes
Marseille, 13273
Institut régional du Cancer Montpellier
Montpellier, 34298
Polyclinique De Gentilly
Nancy, 54100
Centre Antoine Lacassagne
Nice, 06189
Institut de cancerologie du Gard
Nîmes, 30029
Institut Curie
Paris, 75231
Ch Pitie Salpetriere
Paris, 75651
Polyclinique Francheville
Périgueux, 24000
Clinique Armoricaine Radiologie
Plérin, 22190
Chu De Poitiers
Poitiers, 86021
Institut Jean Godinot
Reims, 51056
Centre Eugene Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
ICL
Saint Prient En Jarez, 42271
Centre Rene Huguenin
Saint-Cloud, 92210
Ico Rene Gauducheau
Saint-Herblain, 44805
Institut d'oncologie de l'Orangerie
Strasbourg, 67010
Hopital Hautepierre
Strasbourg, 67098
Institut Claudius Regaud
Toulouse, 31052
Clinique Pasteur
Toulouse, 31076
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94800
Spain40 sites
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, LA Coruna, 15006
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
A Coruña, 15009
Hospital del Mar
Barcelona, 08003
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Clínic i Provincial
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Duran i Reynals
Barcelona, 08908
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital Provincial de Castellon
Castellon, Castellon, 12002
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
IInstituto Oncologico de San Sebastian, Oncologikoa
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080
Hospital General Universitario de Elche
Elche, Alicante, 03202
Hospital Juan Ramon Jimenez
Huelva, 21005
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaén, 23007
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Lerida, 25198
Centro Oncologico MD Anderson Internacional
Madrid, 28033
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital General Universitario Gregorio Marañon
Madrid, 28041
Hospital Universitario 12 de Octubre
Madrid, 28041
Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Malaga, 29010
Hospital General Universitario J.M Morales Meseguer
Murcia, 30008
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Barcelona, 08208
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Univ. Nuestra Señora de Valme
Seville, 41014
Complejo Hospitalario de Toledo- H. Virgen de la Salud
Toledo, 45004
Instituto Valenciano Oncologia
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015
Hospital Universitario la Fe
Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, 50009
Italy28 sites
AORN'S.G.Moscati
Avellino, Campania, 83100
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, 33081
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138
Ospedale Di Bolzano
Bolzano, Trentino-Alto Adige, 39100
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123
Ospedale Antonio Perrino
Brindisi, Apulia, 72100
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
Candiolo, Piedmont, 10060
Ospedale Ramazzini
Carpi, Emilia-Romagna, 41012
Campus Universitario S.Venuta
Catanzaro, Calabria, 88100
Ospedale S. Croce Di Fano
Fano, The Marches, 61032
Ente Ospedaliero Ospedali Galliera
Genoa, Liguria, 16128
Az. Osp. Uni Ria San Martino
Genoa, Liguria, 16132
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
Genoa, Liguria, 16132
Asst Di Lecco
Lecco, Lombardy, 23900
Ospedale Mater Salutis
Legnago, Lombardy, 37045
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
Policlinico di Monza
Monza, Lombardy, 20052
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, Campania, 80131
Ist. Uni Federico Ii
Naples, Campania, 80131
IRCCS Fondazione Maugeri
Pavia, Lombardy, 27100
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, 06132
Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro
Prato, Tuscany, 59100
Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
Az. Osp. Di Busto P.O. Di Saronno
Saronno, Lombardy, 21047
Azienda Ospedaliera S. Maria - Terni
Terni, Umbria, 05100
Divisione Onc Med dell'Azienda
Udine, Friuli Venezia Giulia, 33100
Ospedale Belcolle Di Viterbo
Viterbo, Lazio, 01100
Japan25 sites
Aichi Cancer Center Hospital, Breast Oncology
Aichi, 464-8681
Chiba Cancer Center
Chiba, 260-8717
National Cancer Center Hospital East
Chiba, 277-8577
Natl Hosp Org Shikoku
Ehime, 791-0280
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Gunma University Hospital
Gunma, 371-8511
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Sagara Hospital
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 Shinto General Hospital
Kumamoto, 862-8655
Kyoto University Hospital
Kyoto, 606-8507
Niigata Cancer Ctr Hospital
Niigata, 951-8566
Iwate Med Univ School of Med
Numakunai, 028-3695
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Osaka International Cancer Institute
Osaka, 541-8567
Saitama Medical University International Medical Center
Saitama, 350-1298
Saitama Cancer Center, Breast Oncology
Saitama, 362-0806
Shizuoka Cancer Center
Shizuoka, 411-8777
Shizuoka General Hospital
Shizuoka, 420-8527
Jichi Medical School
Tochigi, 329-0498
National Cancer Center Hospital
Tokyo, 104-0045
Tokyo Metropolitan
Tokyo, 113-8677
The Cancer Inst. Hosp. of JFCR
Tokyo, 135-8550
Tokyo Medical Uni. Hospital
Tokyo, 160-0023
United Kingdom25 sites
Royal Berkshire Hospital
Berkshire, RG1 5AN
Velindre Cancer Centre
Cardiff, CF14 2TL
Cheltenham General Hospital
Cheltenham, GL53 7AN
Colchester General Hospital
Colchester, Essex, CO4 5JL
University Hospital coventry
Coventry, CV2 2DX
Western General Hospital
Edinburgh, EH4 2XU
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
Ipswich Hospital
Ipswich, IP4 5PD
St James Uni Hospital
Leeds, LS9 7TF
St. Bartholomew'S Hospital
London, EC1A 7BE
UCL Hospital NHS Trust
London, NW1 2PG
Royal Marsden Hospital
London, SW3 6JJ
Christie Hospital
Manchester, M20 4BX
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY
Mount Vernon Hospital
Northwood, HA6 2RN
Nottingham City Hospital
Nottingham, NG5 1PB
Churchill Hospital
Oxford, OX3 7LJ
Peterborough City Hospital, Edith Cavell Campus
Peterborough, PE3 9GZ
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Royal Preston Hosp
Preston, PR2 9HT
Weston Park Hospital
Sheffield, S10 2SJ
Uni Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG
Royal Marsden Hosp NHS Fnd
Sutton, SM2 5PT
Royal Cornwall Hospital
Truro, TR1 3LJ
New Cross Hospital
Wolverhampton, WV10 0QP
Canada23 sites
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta, T2N 4N2
Cross Can Inst
Edmonton, Alberta, T6G 1Z2
Northeastern Ontario
Greater Sudbury, Ontario, P3E 5J1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
BC Cancer Agency, CSI
Kelowna, British Columbia, V1Y 5L3
Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9
London Health Sciences Centre
London, Ontario, N6A 5A5
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1
Hopital Maisonneuve- Rosemont
Montreal, Quebec, H1T 2M4
Hopital Sacre-Coeur Research Centre
Montreal, Quebec, H4J 1C5
Southlake Regional Health Center
Newmarket, Ontario, L3Y 2R2
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Hopital du Saint Sacrement
Québec, G1J 1Z4
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Niagara Health Systems - St. Catherines General Site
St. Catharines, Ontario, L2R 7C6
BC Cancer ? Surrey
Surrey, British Columbia, V3V 1Z2
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Bcca - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R2H 2A6
China22 sites
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071
Jilin Cancer Hospital
Changchun, 130012
the First Hospital of Jilin University
Changchun, 130021
Hu Nan Provincial Cancer Hospital
Changsha, 410006
Sichuan Provincial People's Hospital
Chengdu, 610072
Fujian Medical University Union Hospital
Fujian, 350001
The 900th Hospital of PLA joint service support force
Fuzhou, 110016
Sun Yet-sen University Cancer Center
Guangzhou, 510060
Guangdong General Hospital
Guangzhou, 510080
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003
Harbin Medical University Cancer Hospital; Dept. of Breast Surgery
Harbin, 150081
Harbin Medical University Cancer Hospital
Harbin, 150081
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, 200025
Fudan University Shanghai Cancer Center
Shanghai, 200032
Shanghai First People's Hospital
Shanghai, 200080
Changhai Hospital of Shanghai
Shanghai, 200433
Hebei Medical University Fourth Hospital
Shijiazhuang, 50011
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
Hubei Cancer Hospital
Wuhan, 430079
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Wesley Medical Centre
Auchenflower, Queensland, 4066
Mater Hospital
Brisbane, Queensland, 4101
Monash Medical Centre
EAST Bentleigh, Victoria, VIC 3165
Geelong Hospital
Geelong, Victoria, 3220
Austin Hospital
Heidelberg, Victoria, 3084
Royal Hobart Hospital
Hobart, Tasmania, 7000
Lismore Base Hospital
Lismore, New South Wales, 2480
Peter Maccallum Cancer Institute
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Mater Misericordiae Hospital
Sydney, New South Wales, 2060
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2298
Westmead Hospital
Westmead, New South Wales, 2145
Austria11 sites
Lkh-Univ. Klinikum Graz
Graz, 8036
Tiroler Landeskrankenanstalten Ges.M.B.H.
Innsbruck, 6020
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010
Lhk Feldkirch
Rankweil, 6830
Lkh Salzburg - Univ. Klinikum Salzburg
Salzburg, 5020
A. Ö. Krankenhaus Der Barmherzigen Brüder
Sankt Veit an der Glan, 9300
Medizinische Universität Wien; Klinik für Frauenheilkunde
Vienna, 1090
Medizinische Universität Wien; Klinik für Innere Medizin; Abteilung für Onkologie
Vienna, 1090
Krankenhaus Der Stadt Wien-Hietzing
Vienna, 1130
Lkh Vöcklabruck
Vöcklabruck, 4840
Klinikum Kreuzschwestern Wels
Wels, 4600
Mexico11 sites
Médicos Especialistas en Cáncer SC
Aguascalientes, 20230
Centro Estatal de Oncología de Campeche
Campehe, Campeche, 24096
Centro Estatal De Cancerologia De Durango
Durango, 34000
Núcleo de Especialidades Oncológicas
Guadalajara, Jalisco, 44670
Fundacion Rodolfo Padilla Padilla A.C.
León, Guanajuato, 37000
Hospital General de México
Mexico City, Mexico CITY (federal District), 06726
Hospital Angeles Metropolitano
Mexico City, Mexico CITY (federal District), 06760
Centro Universitario Contra El Cancer
Monterrey, Nuevo León, 64020
Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
Montrrey, Nuevo León, 64710
Oaxaca Site Management Organization
Oaxaca City, Oaxaca, 68000
Cancerologia de Queretaro
Querétaro, 76178
Belgium9 sites
Institut Jules Bordet
Anderlecht, 1070
GHdC Site Les Viviers
Charleroi, 6060
UZ Antwerpen
Edegem, 2650
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
AZ Groeninge
Kortrijk, 8500
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Liège (Sart Tilman)
Liège, 4000
Clinique Ste-Elisabeth
Namur, 5000
ZAS Sint Augustinus Wilrijk
Wilrijk, 2610
Denmark9 sites
Aalborg Universitetshospital
Aalborg, 9000
Rigshospitalet
Copenhagen, 2100
Sydvestjysk Sygehus Esbjerg
Esbjerg, 6700
Herlev Hospital
Herlev, 2730
Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
Hillerød, 3400
Sjællands Universitetshospital, Næstved
Næstved, 4700
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, 5000
Sygehus Syd Roskilde
Roskilde, 4000
Vejle Sygehus
Vejle, 7100
Hungary7 sites
Orszagos Onkologiai Intezet
Budapest, 1122
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, H-1134
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Békés Megyei Pándy Kálmán Kórház
Gyula, 5700
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6701
Ireland7 sites
Cork Uni Hospital
Cork
Mater Misericordiae Uni Hospital
Dublin, 7
St. James Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
St Vincent'S Uni Hospital
Dublin
Galway University Hospital
Galway
University Hospital Limerick - Oncology
Limerick
Taiwan7 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Medical Uni Chung-Ho Hospital
Kaohsiung City, 807
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung Uni Hospital
Tainan, 704
Veterans General Hospital
Taipei, 00112
National Taiwan Uni Hospital
Taipei, 100
Tri-Service General Hospital, Division of General Surgery
Taipei, 114
Ukraine7 sites
Cherkassy Regional Oncological Hospital
Cherkassy, 18009
State Medical Academy
Dnipropetrovsk, 43102
Ivano-Frankivsk Regional Oncology Center
Ivano-Frankivsk, 76018
Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
Kiev, 03115
Volyn Regional Oncology Dispensary
Lutsk, 43018
Lvov State Regional Oncology Medical & Diagnostic Center
Lviv, 79031
Ternopil State Medical Academy
Ternopil, 46023
Poland6 sites
Bialostockie Ctr Onkologii
Bialystok, 15-027
Centrum Onkologii
Bydgoszcz, 85-796
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk, 80-214
Opolskie Centrum Onkologii
Opole, 45-060
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, 02-781
NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie
Wieliszew, 05-135
Russia6 sites
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', Tatarstan Republic, 420029
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, Moscow Oblast, 115478
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045
Tula Regional Oncology Dispensary
Tula, 300053
South Korea6 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Seoul National Uni Hospital
Seoul, 110-744
Yonsei University Severance Hospital
Seoul, 120-752
Kyunghee University Hospital
Seoul, 130-702
Samsung Medical Centre
Seoul, 135-170
Korea University Anam Hospital
Seoul, 136-705
Israel5 sites
Rambam Medical Center
Haifa, 3109601
Rabin MC
Petah Tikva, 49100
Chaim Sheba Medical Center
Ramat Gan, 52621
Kaplan Medical Center
Rehovot, 76100
Sourasky / Ichilov Hospital
Tel Aviv, 6423906
Netherlands5 sites
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
Amphia ziekenhuis, locatie langendijk
Breda, 4819 EV
Reinier de Graaf Gasthuis
Delft, 2625 AD
Academish Ziekenhuis Maastricht (Azm)
Maastricht, 6229 HX
Isala Klinieken
Zwolle, 8011 JW
Sweden5 sites
Sahlgrenska Universitetssjukhuset
Gothenburg, 40036
Uni Hospital Linkoeping
Linköping, 58185
Karolinska University Hospital
Stockholm, S-118 83
Norrlands Universitetssjukhus, Umeå, Cancercentrum
Umeå, 90185
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185
Switzerland5 sites
Universitaetsspital Basel
Basel, 4031
Hôpitaux Universit. de Genève Gynécologique - Oncologie
Geneva, 1211
Luzerner Kantonsspital
Lucerne, 6004
Kantonsspital St. Gallen
Sankt Gallen, 9007
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zurich, 8008
Thailand5 sites
Chiang Rai Prachanukraw Hospital
Chiang Rai, 57000
Lopburi Cancer Hospital
Lopburi, 15000
Buddhachinaraj Phitsanulok Hospital
Phitsanulok, 65000
Songklanagarind Hospital
Songkhla, 90110
Surat Thani Hospital
Surat Thani, 84000
Colombia4 sites
Fundacion Cardioinfantil
Bogotá
Inst. Nacional de Cancerologia
Bogotá
Hospital Pablo Tobon Uribe
Medellin-Antioquia
Oncomedica S.A.
Montería
Czechia4 sites
Masarykuv onkologicky ustav
Brno, 656 53
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Olomouc
Olomouc, 779 00
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Pardubice, 532 03
Peru4 sites
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
Lima, L27
Clinica El Golf
San Isidro, L27 Lima
Clinica Peruana Americana
Trujillo, 13011
Romania4 sites
Emergency University Bucharest Hospital
Bucharest, 050098
Oncology Inst. Cluj-Napoca
Cluj-Napoca, 400015
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Euroclinic Center of Oncology SRL
Iași, 700106
Bulgaria3 sites
UMHAT Tsaritsa Yoanna - ISUL
Sofia, 1527
SHATO - Sofia
Sofia, 1756
SHATOD Dr. Marko Antonov Markov-Varna, EOOD
Varna, 9010
Croatia3 sites
Uni Hospital Split
Split, 21000
General Hospital Varazdin
Varaždin, 42000
Clinical Hospital Centre Zagreb
Zagreb, 10000
Philippines3 sites
University Of Santo Tomas
Manila, 1008
Rizal Medical Center
Pasig, 1605
Veterans Memorial Medical Ctr
Quezon City, Luzon, 1101
South Africa3 sites
National Hospital
Bloemfontein, 9301
Wits Donald Gordon Clinical Trial Centre
Johannesburg, 2193
Steve Biko Academic Hospital
Pretoria, 0002
Chile2 sites
INTOP
Providencia, 7501089
Fundacion Arturo Lopez Perez
Santiago, 7500921
Hong Kong2 sites
Queen Mary Hospital; Dept. of Clinical Oncology
Hong Kong
Queen Mary Hospital; Surgery
Hong Kong
New Zealand2 sites
Waikato Hospital
Hamilton, 3240
Palmerston North Hospital
Palmerston North, 4442
Panama2 sites
Centro Oncologico America
Panama City, 0834-02723
The Panama Clinic
Panama City, 32400
About this study
Official title: A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
- Conditions
- Breast Cancer
- Being tested
- 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
CarboplatinDrug
Carboplatin will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
DocetaxelDrug
Docetaxel will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin will be administered as per the schedule specified in the respective arm.
EpirubicinDrug
Epirubicin will be administered as per the schedule specified in the respective arm.
PaclitaxelDrug
Paclitaxel will be administered as per the schedule specified in the respective arm.
PertuzumabDrug
Also called Perjeta®
Pertuzumab will be administered as per the schedule specified in the respective arm.
PlaceboDrug
Placebo will be administered as per the schedule specified in the respective arm.
TrastuzumabDrug
Also called Herceptin®
Trastuzumab will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy | Experimental | Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg). Receives: Drug: 5-Fluorouracil; Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel; Drug: Pertuzumab; Drug: Trastuzumab |
| Placebo + Trastuzumab + Chemotherapy | Placebo comparator | Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]). Receives: Drug: 5-Fluorouracil; Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin; Drug: Epirubicin; Drug: Paclitaxel; Drug: Placebo; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.
Measured: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.
Measured: 3 years
Secondary outcomes (38)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Measured: 6, 8, and 10 years
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Measured: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Measured: 3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Measured: 6, 8, and 10 years
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Measured: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
Measured: 3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
Measured: 6, 8, and 10 years
Percentage of Participants Who Died, First Interim Overall Survival Analysis
Percentage of participants who died due to any cause is reported.
Measured: Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Percentage of Participants Who Died, Final Overall Survival Analysis
Percentage of participants who died due to any cause is reported.
Measured: Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
Measured: 3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
Measured: 6, 8, and 10 years
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
Measured: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at 3 years is reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Measured: 3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Measured: 6, 8, and 10 years
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.
Measured: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at 3 years is reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Measured: 3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Kaplan-Meier estimates of the percentage of participants who were DRFI event-free at 6, 8, and 10 years are reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
Measured: 6, 8, and 10 years
Percentage of Participants With Primary Cardiac Event, Primary Analysis
Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Measured: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Percentage of Participants With Primary Cardiac Event, Final Analysis
Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.
Measured: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Percentage of Participants With Secondary Cardiac Event, Primary Analysis
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Measured: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Percentage of Participants With Secondary Cardiac Event, Final Analysis
Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).
Measured: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Measured: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis
LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Measured: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
Measured: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of 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. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of 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 symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
Measured: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Trough Serum Concentration (Cmin) of Pertuzumab
Measured: Cycles 1, 10 and 15 (Cycle length=21 days)
Cmin of Trastuzumab
Measured: Cycles 1, 10 and 15 (Cycle length=21 days)
Peak Serum Concentration (Cmax) of Pertuzumab
Measured: Cycles 1, 10 and 15 (Cycle length=21 days)
Cmax of Trastuzumab
Measured: Cycles 1, 10 and 15 (Cycle length=21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study start8 Nov 2011
- Primary completion19 Dec 2016
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc., Breast International Group
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358877
- Sponsor's protocol ID
- BO25126
- Other IDs
- TOC4939G, 2010-022902-41, BIG 4-11
- Acronym
- APHINITY
- Status last verified
- Nov 2025
- First submitted
- 20 May 2011
- Last updated
- 28 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Agostinetto E, Gentile G, Samy F, Di Cosimo S, Aftimos P, Ponde N, Eiger D, Lambertini M, Cameron D, Kiermaier A, Bailey A, Viale G, Loi S, Piccart M, de Azambuja E. The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a subanalysis of the APHINITY trial. J Natl Cancer Inst. 2026 Aug 1;118(8):1504-1513. doi: 10.1093/jnci/djag095.
PubMed 41934626Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber RD, Restuccia E, Im YH, Huang CS, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez HL, Bliss J, Viale G, Bines J, Piccart M; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. J Clin Oncol. 2024 Nov;42(31):3643-3651. doi: 10.1200/JCO.23.02505. Epub 2024 Sep 11.
PubMed 39259927de Azambuja E, Agostinetto E, Procter M, Eiger D, Ponde N, Guillaume S, Parlier D, Lambertini M, Desmet A, Caballero C, Aguila C, Jerusalem G, Walshe JM, Frank E, Bines J, Loibl S, Piccart-Gebhart M, Ewer MS, Dent S, Plummer C, Suter T; APHINITY Steering Committee and Investigators. Cardiac safety of dual anti-HER2 blockade with pertuzumab plus trastuzumab in early HER2-positive breast cancer in the APHINITY trial. ESMO Open. 2023 Feb;8(1):100772. doi: 10.1016/j.esmoop.2022.100772. Epub 2023 Jan 19.
PubMed 36681013Lambertini M, Fielding S, Loibl S, Janni W, Clark E, Franzoi MA, Fumagalli D, Caballero C, Arecco L, Salomoni S, Ponde NF, Poggio F, Kim HJ, Villarreal-Garza C, Pagani O, Paluch-Shimon S, Ballestrero A, Del Mastro L, Piccart M, Bines J, Partridge AH, de Azambuja E. Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy. J Natl Cancer Inst. 2022 Aug 8;114(8):1117-1126. doi: 10.1093/jnci/djac096.
PubMed 35512402Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18.
PubMed 35313167Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7.
PubMed 33828257Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.
PubMed 33539215Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.
PubMed 31924513Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.
PubMed 31305270Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.
PubMed 30976844von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5.
PubMed 28581356