A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
A 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
2 other identifiers
interventional
1,846
36 countries
295
Brief Summary
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jan 2014
Typical duration for phase_3 breast-cancer
295 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedStudy Start
First participant enrolled
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2019
CompletedResults Posted
Study results publicly available
January 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2021
CompletedJune 14, 2022
June 1, 2022
5.8 years
October 17, 2013
November 17, 2020
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.
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
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 Outcomes (9)
IDFS Plus Second Primary Non-Breast Cancer
Baseline up to approximately 70 months
Disease-Free Survival (DFS)
Baseline up to approximately 70 months
Distant Recurrence-Free Interval (DRFI)
Baseline up to approximately 70 months
Overall Survival (OS)
First participant randomized up to approximately 7.5 years
Percentage of Participants With Adverse Events
From randomization to approximately 7.5 years
- +4 more secondary outcomes
Study Arms (2)
Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane
ACTIVE COMPARATORTrastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles \[1 Cycle = 21 days\]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline \[5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)\] based chemotherapy.
Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab
EXPERIMENTALTrastuzumab 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.
Interventions
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).
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).
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).
IV infusion of paclitaxel 80 mg/m\^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (295)
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
Kaiser Permanente - Roseville; Oncology Pharmacy
Roseville, California, 95661, United States
Kaiser Permanente - Sacramento; Oncology Pharmacy
Sacramento, California, 95814, United States
UC Davis Cancer Center; Oncology
Sacramento, California, 95817, United States
Southern California Kaiser Permanente
San Diego, California, 92108, United States
Kaiser Permanente - San Jose
San Jose, California, 95119, United States
Kaiser Permanente - San Leandro
San Leandro, California, 94577, United States
Kaiser Permanente - South SF; Oncology Clinical trials
South San Francisco, California, 94080, United States
Stanford University School of Medicine
Stanford, California, 94305-5151, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek; Oncology Pharmacy
Walnut Creek, California, 94596, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists; Saint Petersburg
St. Petersburg, Florida, 33719, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Central Georgia Cancer Care PC
Macon, Georgia, 31201, United States
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, 62301, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, 21401, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute..
Detroit, Michigan, 48201, United States
Henry Ford Hospital; Hematology Oncology
Detroit, Michigan, 48202, United States
US oncology research at Minnesota Oncology
Saint Paul, Minnesota, 55102, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Memorial Sloan-Kettering Cancer Center
Commack, New York, 11725, United States
ProHEALTH Care Associates LLP
Lake Success, New York, 11042, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Mercy Clinic Oklahoma Communties, Inc
Oklahoma City, Oklahoma, 73120, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
West Clinic
Germantown, Tennessee, 38138, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916-2305, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104, United States
Wellmont Medical Associates
Bristol, Virginia, 24201, United States
University of Virginia Health System; Hematology/Oncology Division
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298, United States
Blue Ridge Cancer Care - Salem
Salem, Virginia, 24153, United States
University of Washington
Seattle, Washington, 98195, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Haematology & Oncology Clinics of Australia Research Centre
South Brisbane, Queensland, 4101, Australia
Burnside War Memorial Hospital, Clinical Trials Centre
Adelaide, South Australia, 5056, Australia
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, 3199, Australia
Austin Hospital; Medical Oncology
Heidelberg, Victoria, 3084, Australia
Epworth HealthCare; Clinical Trials Centre
Richmond, Victoria, 3121, Australia
St John of God Murdoch Hospital; Oncology West
Murdoch, Western Australia, 6150, Australia
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Sint Augustinus Wilrijk, Apotheek
Wilrijk, 2610, Belgium
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 7100, Bosnia and Herzegovina
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, 01308-050, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Hospital Paulistano
São Paulo, São Paulo, 01321-000, Brazil
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, V1Y 5L3, Canada
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Regional health authority A vitalite health network
Moncton, New Brunswick, E1C 8X3, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1, Canada
Southlake Regional Health Center; Community Care Clinic / Oncology
Newmarket, Ontario, L3Y 2P9, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
North York General Hospital
Toronto, Ontario, M2J 1V1, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, H7M 3L9, Canada
McGill University; Glen Site; Oncology
Montreal, Quebec, H4A 3J1, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Instituto Oncologico del sur
Temuco, 4810469, Chile
ONCOCENTRO APYS; Oncología
Viña del Mar, 2520598, Chile
Oncomedica S.A.
Montería, 230002, Colombia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, 500 05, Czechia
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Pardubice, 532 03, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Hospital Diagnostico Escalón
San Salvador, 01101, El Salvador
Ico - Paul Papin
Angers, 49000, France
Clinique Sainte Catherine
Avignon, 84082, France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030, France
Institut Bergonie; Oncologie
Bordeaux, 33076, France
CHU de Brest - Hôpital de Morvan
Brest, 29609, France
Centre Francois Baclesse; Oncologie
Caen, 14076, France
Centre Jean Perrin; Oncologie
Clermont-Ferrand, 63011, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Clinique Victor Hugo; Chimiotherapie
Le Mans, 72015, France
Centre Oscar Lambret; Cancerologie Gynecologique
Lille, 59020, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut de cancerologie du Gard
Nîmes, 30029, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)
Plérin, 22190, France
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, 51057, France
Centre Eugene Marquis; Service d'oncologie
Rennes, 35042, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
Saint-Priest-en-Jarez, 42271, France
Institut d'oncologie de l'Orangerie; Chimiotherapie
Strasbourg, 67010, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54519, France
LTD Institute of Clinical Oncology
Tbilisi, 0159, Georgia
Khechinashvili University Hospital ;Breast Unit
Tbilisi, 0177, Georgia
Chemotherapy and Immunotherapy Clinic Medulla
Tbilisi, 0186, Georgia
Klinikum Augsburg
Augsburg, 86156, Germany
Hochwaldkrankenhaus
Bad Nauheim, 61231, Germany
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, 14169, Germany
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
Bochum, 44787, Germany
Praxis Dr.med. Katja Ziegler-Löhr
Cologne, 50679, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307, Germany
AGAPLESION Markus-Krankenhaus
Frankfurt, 60431, Germany
Städtische Kliniken Frankfurt am Main Höchst
Frankfurt, 65929, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Dres.Jochen Wilke und Harald Wagner
Fürth, 90766, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, 49124, Germany
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, 20246, Germany
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hanover, 30177, Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hanover, 30625, Germany
Klinikum Kulmbach; Frauenklinik
Kulmbach, 95326, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538, Germany
Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
Meiningen, 98617, Germany
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
München, 81377, Germany
Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
Ravensburg, 88212, Germany
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), 27356, Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund, 18439, Germany
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, 53840, Germany
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
Weinheim, 69469, Germany
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
Worms, 67550, Germany
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01010, Guatemala
Grupo Angeles
Guatemala City, 01015, Guatemala
Princess Margaret Hospital; Oncology
Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Surgery
Pokfulam, Hong Kong
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
Budapest, 1145, Hungary
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, 4032, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, 5262100, Israel
Sourasky / Ichilov Hospital; Oncology Department
Tel Aviv, 64239-06, Israel
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, 40138, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, 33081, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, 00128, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, 00144, Italy
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardy, 26100, Italy
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, 20133, Italy
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardy, 20089, Italy
Humanitas Centro Catanese Di Oncologia; Oncologia Medica
Misterbianco (CT), Sicily, 95045, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, 59100, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, 05100, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, 35128, Italy
Aichi Cancer Center Hospital, Breast Oncology
Aichi, 464-8681, Japan
Nagoya City University Hospital; Breast Surgery
Aichi, 467-8602, Japan
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, 811-1395, Japan
Gunma University Hospital; Department of Breast and Endocrine Surgery
Gunma, 371-8511, Japan
Gunma Prefectural Cancer Center; Breast Oncology
Gunma, 373-8550, Japan
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
Hiroshima, 730-8518, Japan
Hiroshima University Hospital; Breast Surgery
Hiroshima, 734-8551, Japan
Hyogo College Of Medicine; Breast And Endocrine Surgery
Hyōgo, 663-8501, Japan
Sagara Hospital; Breast Surgery
Kagoshima, 892-0833, Japan
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
Kanagawa, 216-8511, Japan
Tokai University Hospital, Breast Surgery
Kanagawa, 259-1193, Japan
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, 862-8505, Japan
Kumamoto Shinto General Hospital; Breast Cancer Center
Kumamoto, 862-8655, Japan
Kyoto University Hospital; Breast Surgery
Kyoto, 606-8507, Japan
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, 951-8566, Japan
Iwate Med Univ School of Med; Surgery
Numakunai, 028-3695, Japan
Kawasaki Medical School Hospital; Breast and Thyroid Surgery
Okayama, 701-0114, Japan
Naha-nishi Clinic; Surgery
Okinawa, 901-0154, Japan
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, 540-0006, Japan
Osaka International Cancer Institute; Breast and Endocrine Surgery
Osaka, 541-8567, Japan
Saitama Medical University International Medical Center; Breast Oncology
Saitama, 350-1298, Japan
Saitama Cancer Center, Breast Oncology
Saitama, 362-0806, Japan
Shizuoka Cancer Center; Breast Surgery
Shizuoka, 411-8777, Japan
Shizuoka General Hospital; Breast Surgery
Shizuoka, 420-8527, Japan
Jichi Medical University; Breast Oncology
Tochigi, 329-0498, Japan
National Cancer Center Hospital; Medical Oncology
Tokyo, 104-0045, Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo, 104-8560, Japan
Tokyo Metropolitan; Komagome Hospital, Surgery
Tokyo, 113-8677, Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, 135-8550, Japan
Showa University Hospital; Breast Surgery
Tokyo, 142-8666, Japan
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, 160-0023, Japan
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
Distrito Federal, 14000, Mexico
Fundacion Rodolfo Padilla Padilla A.C.
León, 37000, Mexico
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, 03100, Mexico
Hospital San Jose Del Tec. de Monterrey; Oncology
Monterrey, 64020, Mexico
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Oslo, 0450, Norway
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
Stavanger, 4011, Norway
Centro Hemato Oncologico Panama
Panama City, 0832, Panama
Clinica de Especialidades Medicas
Lima, Lima 41, Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41, Peru
Clinica San Borja
Lima, Lima 41, Peru
Instituto Oncologico Miraflore
Miraflores, Lima 18, Peru
San Juan de Dios Hospital;Oncology Unit
Pasay, 1300, Philippines
East Avenue Medical Center
Quezon City, 1100, Philippines
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, 15-027, Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-214, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 30-688, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
Lodz, 93-513, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin, 20-090, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, 05-400, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warsaw, 02-781, Poland
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
Bucharest, 022328, Romania
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, 400006, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Regional Institute of Oncology Iasi
Iași, 700483, Romania
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
Kazan', 420029, Russia
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, 115478, Russia
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, 460021, Russia
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
Ryazan, 390011, Russia
Scientific Research Institute n.a. N.N. Petrov
Saint Petersburg, 197758, Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228, Singapore
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
National Cancer Center; Medical Oncology
Gyeonggi-do, 410-769, South Korea
Ajou Uni Hospital; Medical Oncology
Gyeonggi-do, 443-380, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, 08907, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, 28033, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, 413 45, Sweden
Universitetssjukhuset Örebro, Onkologiska kliniken
Örebro, 701 85, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 751 85, Sweden
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur, 7000, Switzerland
Luzerner Kantonsspital; Medizinische Onkologie
Lucerne, 6004, Switzerland
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zurich, 8008, Switzerland
Changhua Christian Hospital; Dept of Surgery
Changhua, 500, Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital; Dept of Surgery
Taichung, 407, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, 100, Taiwan
Tri-Service General Hospital, Division of General Surgery
Taipei, 114, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Chiang Rai Prachanukroh Hospital; Department Of Medicine
Chiang Rai, 57000, Thailand
Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
Phitsanuok, 65000, Thailand
State Medical Academy; Oncology
Dnipropetrovsk, 43102, Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Velindre Cancer Centre; Oncology Dept
Cardiff, CF14 2TL, United Kingdom
Cheltenham General Hospital; Gloucestershire Oncology Centre
Cheltenham, GL53 7AN, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall, TR1 3LQ, United Kingdom
University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre
Coventry, CV2 2DX, United Kingdom
Western General Hospital; Edinburgh Breast Unit
Edinburgh, EH4 2XU, United Kingdom
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, EX2 5DW, United Kingdom
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, GU2 7XX, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department
London, SW3 6JJ, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Maidstone Hospital; Kent Oncology Centre
Maidstone, ME16 9QQ, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne, NE7 7DN, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB, United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, PE3 9GZ, United Kingdom
Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
Portsmouth, PO6 3LY, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
Musgrove Park Hospital; Department Clinical Research, Beacon Centre
Somerset, TA1 5DA, United Kingdom
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
Stoke-on-Trent, ST4 6QG, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, BA21 4AT, United Kingdom
Related Publications (1)
Krop IE, Im SA, Barrios C, Bonnefoi H, Gralow J, Toi M, Ellis PA, Gianni L, Swain SM, Im YH, De Laurentiis M, Nowecki Z, Huang CS, Fehrenbacher L, Ito Y, Shah J, Boulet T, Liu H, Macharia H, Trask P, Song C, Winer EP, Harbeck N. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol. 2022 Feb 10;40(5):438-448. doi: 10.1200/JCO.21.00896. Epub 2021 Dec 10.
PMID: 34890214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 21, 2013
Study Start
January 31, 2014
Primary Completion
November 27, 2019
Study Completion
June 4, 2021
Last Updated
June 14, 2022
Results First Posted
January 12, 2021
Record last verified: 2022-06