Clinical trial NCT01966471: 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
Official title: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 1846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1
* Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
* HER2-positive breast cancer
* Known hormone receptor status of the primary tumor
* Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
* Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer \[UICC/AJCC\] 7th edition): eligible participants must have either:

Node-positive disease (pN more than or equal to \[\>/=\] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size \>2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory

* Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive
* No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
* Baseline left ventricular ejection fraction (LVEF) \>/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans
* Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required
* Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment

Exclusion Criteria:

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

Primary outcomes:
measure: Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
timeFrame: 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.
measure: Invasive Disease-Free Survival (IDFS) in the Overall Population
timeFrame: First participant randomized up to approximately 7.5 years
Secondary outcomes:
measure: IDFS Plus Second Primary Non-Breast Cancer
timeFrame: Baseline up to approximately 70 months
measure: Disease-Free Survival (DFS)
timeFrame: Baseline up to approximately 70 months
measure: Distant Recurrence-Free Interval (DRFI)
timeFrame: Baseline up to approximately 70 months
measure: Overall Survival (OS)
timeFrame: First participant randomized up to approximately 7.5 years
measure: Percentage of Participants With Adverse Events
timeFrame: From randomization to approximately 7.5 years
measure: Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
timeFrame: First participant randomized up to approximately 7.5 years.
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
timeFrame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
measure: EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
timeFrame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
measure: Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
timeFrame: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute - Bisgrove
state: Arizona
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville; Oncology Pharmacy
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente - Sacramento; Oncology Pharmacy
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center; Oncology
state: California
city: San Diego
country: United States
facility: Southern California Kaiser Permanente
state: California
city: San Jose
country: United States
facility: Kaiser Permanente - San Jose
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente - San Leandro
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente - South SF; Oncology Clinical trials
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek; Oncology Pharmacy
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; SCRI
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists; Saint Petersburg
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC; Research
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care PC
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group; Canc Ctr at Blessing Hosp
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Med Ctr
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute..
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital; Hematology Oncology
state: Michigan
city: Saint Paul
country: United States
facility: US oncology research at Minnesota Oncology
state: Minnesota
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Med Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Lake Success
country: United States
facility: ProHEALTH Care Associates LLP
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oklahoma Communties, Inc
state: Oklahoma
city: Pittsburgh
country: United States
facility: Magee-Woman's Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders - Fort Worth
state: Texas
city: Bristol
country: United States
facility: Wellmont Medical Associates
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health System; Hematology/Oncology Division
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Salem
country: United States
facility: Blue Ridge Cancer Care - Salem
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: South Brisbane
country: Australia
facility: Haematology & Oncology Clinics of Australia Research Centre
state: Queensland
city: Adelaide
country: Australia
facility: Burnside War Memorial Hospital, Clinical Trials Centre
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital; Oncology/Haematology
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital; Medical Oncology
state: Victoria
city: Richmond
country: Australia
facility: Epworth HealthCare; Clinical Trials Centre
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital; Oncology West
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk, Apotheek
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama
state: GO
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes; Centro de Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
state: British Columbia
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Moncton
country: Canada
facility: Regional health authority A vitalite health network
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Center; Community Care Clinic / Oncology
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Montreal
country: Canada
facility: McGill University; Glen Site; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Temuco
country: Chile
facility: Instituto Oncologico del sur
city: Vina Del Mar
country: Chile
facility: ONCOCENTRO APYS; Oncología
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
city: Pardubice
country: Czechia
facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: San Salvador
country: El Salvador
facility: Hospital Diagnostico Escalón
city: Angers
country: France
facility: Ico - Paul Papin
city: Avignon
country: France
facility: Clinique Sainte Catherine
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Bordeaux
country: France
facility: Institut Bergonie; Oncologie
city: Brest
country: France
facility: CHU de Brest - Hôpital de Morvan
city: Caen
country: France
facility: Centre Francois Baclesse; Oncologie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Oncologie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Le Mans
country: France
facility: Clinique Victor Hugo; Chimiotherapie
city: Lille
country: France
facility: Centre Oscar Lambret; Cancerologie Gynecologique
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Institut de cancerologie du Gard
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Plerin
country: France
facility: Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)
city: Reims
country: France
facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie
city: Rennes
country: France
facility: Centre Eugene Marquis; Service d'oncologie
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: St Priest En Jarez
country: France
facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
city: Strasbourg
country: France
facility: Institut d'oncologie de l'Orangerie; Chimiotherapie
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Tbilisi
country: Georgia
facility: LTD Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: Khechinashvili University Hospital ;Breast Unit
city: Tbilisi
country: Georgia
facility: Chemotherapy and Immunotherapy Clinic Medulla
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Nauheim
country: Germany
facility: Hochwaldkrankenhaus
city: Berlin
country: Germany
facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
city: Bochum
country: Germany
facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Frankfurt
country: Germany
facility: AGAPLESION Markus-Krankenhaus
city: Frankfurt
country: Germany
facility: Städtische Kliniken Frankfurt am Main Höchst
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Fürth
country: Germany
facility: Dres.Jochen Wilke und Harald Wagner
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
city: Hannover
country: Germany
facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
city: Kulmbach
country: Germany
facility: Klinikum Kulmbach; Frauenklinik
city: Köln
country: Germany
facility: Praxis Dr.med. Katja Ziegler-Löhr
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
city: Meiningen
country: Germany
facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
city: Muenchen
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
city: Ravensburg
country: Germany
facility: Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
city: Rotenburg/Wümme
country: Germany
facility: Agaplesion Diakonieklinikum Rotenburg
city: Stralsund
country: Germany
facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
city: Troisdorf
country: Germany
facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
city: Worms
country: Germany
facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Guatemala
country: Guatemala
facility: Centro Oncológico Sixtino / Centro Oncológico SA
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital; Oncology
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital; Clinical Oncology
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital; Dept of Surgery
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Oncology Department
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS
state: Lazio
city: Cremona
country: Italy
facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
state: Lombardia
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Misterbianco (CT)
country: Italy
facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica
state: Sicilia
city: Prato
country: Italy
facility: Ospedale Misericordia E Dolce; Oncologia Medica
state: Toscana
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria - Terni; Oncologia
state: Umbria
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital, Breast Oncology
city: Aichi
country: Japan
facility: Nagoya City University Hospital; Breast Surgery
city: Ehime
country: Japan
facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology
city: Gunma
country: Japan
facility: Gunma University Hospital; Department of Breast and Endocrine Surgery
city: Gunma
country: Japan
facility: Gunma Prefectural Cancer Center; Breast Oncology
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital; Breast Surgery
city: Hyogo
country: Japan
facility: Hyogo College Of Medicine; Breast And Endocrine Surgery
city: Iwate
country: Japan
facility: Iwate Med Univ School of Med; Surgery
city: Kagoshima
country: Japan
facility: Sagara Hospital; Breast Surgery
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
city: Kanagawa
country: Japan
facility: Tokai University Hospital, Breast Surgery
city: Kumamoto
country: Japan
facility: Kumamoto City Hospital, Breast and Endocrine Surgery
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital; Breast Cancer Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital; Breast Surgery
city: Niigata
country: Japan
facility: Niigata Cancer Ctr Hospital; Breast Surgery
city: Okayama
country: Japan
facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery
city: Okinawa
country: Japan
facility: Naha-nishi Clinic; Surgery
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital; Breast Surgery
city: Osaka
country: Japan
facility: Osaka International Cancer Institute; Breast and Endocrine Surgery
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center; Breast Oncology
city: Saitama
country: Japan
facility: Saitama Cancer Center, Breast Oncology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Breast Surgery
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital; Breast Surgery
city: Tochigi
country: Japan
facility: Jichi Medical University; Breast Oncology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Medical Oncology
city: Tokyo
country: Japan
facility: St. Luke's Internat. Hospital, Breast Surgical Oncology
city: Tokyo
country: Japan
facility: Tokyo Metropolitan; Komagome Hospital, Surgery
city: Tokyo
country: Japan
facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
city: Tokyo
country: Japan
facility: Showa University Hospital; Breast Surgery
city: Tokyo
country: Japan
facility: Tokyo Medical Uni. Hospital; Breast Oncology
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center; Medical Oncology
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou Uni Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Distrito Federal
country: Mexico
facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
city: León
country: Mexico
facility: Fundacion Rodolfo Padilla Padilla A.C.
city: Mexico City
country: Mexico
facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
city: Monterrey
country: Mexico
facility: Hospital San Jose Del Tec. de Monterrey; Oncology
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret
city: Stavanger
country: Norway
facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
city: Panama
country: Panama
facility: Centro Hemato Oncologico Panama
city: Lima
country: Peru
facility: Clinica de Especialidades Medicas
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
city: Lima
country: Peru
facility: Clinica San Borja
city: Miraflores
country: Peru
facility: Instituto Oncologico Miraflore
city: Pasay
country: Philippines
facility: San Juan de Dios Hospital;Oncology Unit
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
city: Warszawa
country: Poland
facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Cluj Clinical County Hospital; Oncology Dept
city: Iasi
country: Romania
facility: Regional Institute of Oncology Iasi
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
city: Orenburg
country: Russian Federation
facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
city: Ryazan
country: Russian Federation
facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Institute n.a. N.N. Petrov
city: Samara
country: Russian Federation
facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset; Jubileumskliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro, Onkologiska kliniken
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital; Medizinische Onkologie
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Dept of Surgery
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital; Dept of Surgery
city: Taipei
country: Taiwan
facility: VETERANS GENERAL HOSPITAL; Department of General Surgery
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; General Surgery
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, Division of General Surgery
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Chiang Rai
country: Thailand
facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine
city: Phitsanuok
country: Thailand
facility: Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
city: Dnipropetrovsk
country: Ukraine
facility: State Medical Academy; Oncology
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre; Oncology Dept
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital; Gloucestershire Oncology Centre
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital; Dept of Clinical Oncology
city: Coventry
country: United Kingdom
facility: University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre
city: Edinburgh
country: United Kingdom
facility: Western General Hospital; Edinburgh Breast Unit
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital; Oncology Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital; St. Lukes Cancer Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Medical Oncology
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Fulham; Oncology Department
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital; Kent Oncology Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: New Castle Upon Tyne
country: United Kingdom
facility: Freeman Hospital; Northern Centre For Cancer Care
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Oncology
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital; Cancer Clinical Trials Centre
city: Somerset
country: United Kingdom
facility: Musgrove Park Hospital; Department Clinical Research, Beacon Centre
city: Stoke-on-Trent
country: United Kingdom
facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital; Macmillan Cancer Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.