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 (APHINITY)
March 18, 2024 updated by: Hoffmann-La Roche
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).
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
4804
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Miguel de Tucuman, Argentina, T4000IAK
- Centro Medico San Roque
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Santa Fe, Argentina, S3000XAE
- Isis Centro Especializado de Luces; Oncology
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New South Wales
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Lismore, New South Wales, Australia, 2480
- Lismore Base Hospital; Cancer Care & Haematology Unit
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Sydney, New South Wales, Australia, 2060
- Mater Misericordiae Hospital; Chemotherapy Cottage
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Waratah, New South Wales, Australia, 2298
- Newcastle Mater Misericordiae Hospital; Oncology
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital; Medical Oncology and Pallative Care
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Queensland
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Auchenflower, Queensland, Australia, 4066
- Wesley Medical Centre; Clinic For Haematology and Oncology
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Brisbane, Queensland, Australia, 4101
- Mater Hospital; Oncology
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital; Oncology
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Tasmania
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Hobart, Tasmania, Australia, 7000
- Royal Hobart Hospital; Medical Oncology
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre; Oncology
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Geelong, Victoria, Australia, 3220
- Geelong Hospital; Andrew Love Cancer Centre
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital; Medical Oncology
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Melbourne, Victoria, Australia, 3000
- Peter Maccallum Cancer Institute; Medical Oncology
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Western Australia
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Perth, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital; Medical Oncology
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Graz, Austria, 8036
- Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
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Innsbruck, Austria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
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Linz, Austria, 4010
- Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
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Rankweil, Austria, 6830
- Lhk Feldkirch; Interne Medizin Abt.
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Salzburg, Austria, 5020
- Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
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St Veit An Der Glan, Austria, 9300
- A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.
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Vöcklabruck, Austria, 4840
- Lkh Vöcklabruck; I. Abt. Für Innere Medizin
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Wels, Austria, 4600
- Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
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Wien, Austria, 1090
- Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
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Wien, Austria, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
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Wien, Austria, 1130
- Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
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Anderlecht, Belgium, 1070
- Institut Jules Bordet
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Charleroi, Belgium, 6000
- GHdC Site Notre Dame
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Edegem, Belgium, 2650
- UZ Antwerpen
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Hasselt, Belgium, 3500
- Jessa Zkh (Campus Virga Jesse)
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Kortrijk, Belgium, 8500
- AZ Groeninge
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Liège, Belgium, 4000
- CHU Sart-Tilman
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Namur, Belgium, 5000
- Clinique Ste-Elisabeth
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Wilrijk, Belgium, 2610
- Sint Augustinus Wilrijk
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Sofia, Bulgaria, 1756
- SHATO - Sofia
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Sofia, Bulgaria, 1527
- UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy
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Varna, Bulgaria, 9010
- SHATOD Dr. Marko Antonov Markov-Varna, EOOD
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre; Dept of Medicine
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Can Inst
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer Agency, CSI
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Surrey, British Columbia, Canada, V3V 1Z2
- BC Cancer ? Surrey
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Victoria, British Columbia, Canada, V8R 6V5
- Bcca - Vancouver Island Cancer Centre; Oncology
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- CancerCare Manitoba; Neuro-Oncology
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
- Atlantic Health Science Corporation; Saint John Regional Hospital Facility
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Queen Elizabeth II Health Sciences Centre; Oncology
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Hamilton Health Sciences - Juravinski Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Centre of Southeastern Ontario; Kingston General Hospital
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London, Ontario, Canada, N6A 4L6
- London Health Sciences Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
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Newmarket, Ontario, Canada, L3Y 2R2
- Southlake Regional Health Center
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
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St. Catharines, Ontario, Canada, L2R 7C6
- Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario; Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Toronto, Ontario, Canada, M5G 1Z5
- Princess Margaret Cancer Center
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Odette Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Hopital Maisonneuve- Rosemont; Oncology
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Montreal, Quebec, Canada, H4J 1C5
- Hopital Sacre-Coeur Research Centre
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Montreal, Quebec, Canada, H2L 4M1
- Chum Hopital Notre Dame; Centre D'Oncologie
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Quebec City, Quebec, Canada, G1S 4L8
- Hopital du Saint Sacrement
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Providencia, Chile, 7501089
- INTOP
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Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez
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Beijing, China, 100021
- Cancer Hospital Chinese Academy of Medical Sciences.
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Beijing, China, 100071
- The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
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Changchun, China, 130021
- The First Hospital of Jilin University
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Changchun, China, 132013
- Jilin Cancer Hospital
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Changsha, China, 410006
- Hu Nan Provincial Cancer Hospital
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Chengdu, China, 610072
- Sichuan Provincial People's Hospital
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Fuzhou, China, 110016
- The 900th Hospital of PLA joint service support force
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Fuzhou City, China, 350001
- Fujian Medical University Union Hospital
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Guangzhou, China, 510080
- Guangdong General Hospital
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Guangzhou City, China, 510663
- Sun Yet-sen University Cancer Center
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Hangzhou, China, 310003
- The First Affiliated Hospital of College of Medicine, Zhejiang University
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Harbin, China, 150081
- Harbin Medical University Cancer Hospital
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Nanchang, China, 330019
- The 1st Affiliated Hospital of Nanchang Unversity
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Shanghai, China, 200025
- Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
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Shanghai, China, 200080
- Shanghai First People's Hospital
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Shanghai, China, 200433
- Changhai Hospital of Shanghai
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Shanghai City, China, 200120
- Fudan University Shanghai Cancer Center
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Shijiazhuang, China, 050035
- Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
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Wuhan, China, 430030
- Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
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Wuhan, China, 430079
- Hubei Cancer Hospital
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Wuhan, China, 430022
- Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
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Bogota, Colombia
- Fundacion Cardioinfantil
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Bogota, Colombia, 111511
- Inst. Nacional de Cancerologia; Clinica de Seno
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Medellin, Colombia, 050034
- Hospital Pablo Tobon Uribe
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Monteria, Colombia, 230002
- Oncomedica S.A.
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Split, Croatia, 21000
- Uni Hospital Split; Oncology & Radiotherapy
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Varazdin, Croatia, 42000
- General Hospital Varazdin
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Zagreb, Croatia, 10000
- Clinical Hospital Centre Zagreb
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Brno, Czechia, 656 53
- Masarykuv onkologicky ustav
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Hradec Kralove, Czechia, 500 05
- Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
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Olomouc, Czechia, 779 00
- Fakultni nemocnice Olomouc; Onkologicka klinika
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Pardubice, Czechia, 532 03
- MULTISCAN, s.r.o., Radiologicke centrum Pardubice
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Aalborg, Denmark, 9000
- Aalborg Universitetshospital; Onkologisk Afdeling
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Esbjerg, Denmark, 6700
- Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling
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Herlev, Denmark, 2730
- Herlev Hospital; Afdeling for Kræftbehandling
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Hillerod, Denmark, 3400
- Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
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København Ø, Denmark, 2100
- Rigshospitalet; Onkologisk Klinik
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Naestved, Denmark, 4700
- Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
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Odense C, Denmark, 5000
- Odense Universitetshospital, Onkologisk Afdeling R
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Roskilde, Denmark, 4000
- Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
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Vejle, Denmark, 7100
- Vejle Sygehus; Onkologisk Afdeling
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Salvador, El Salvador, 01101
- Hospital Oncologia; Oncology
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San Salvador, El Salvador, 01101
- Hospital Diagnostico Escalón
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Amiens, France, 80090
- Clinique De L Europe; Pmsi
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Angers, France, 49055
- ICO Paul Papin; Oncologie Medicale.
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Arras, France, 62012
- HOP Prive Arras Les Bonnettes; Chimiotherapie
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Avignon, France, 84082
- Institut Sainte Catherine
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Bezannes, France, 51430
- ICONE
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Bordeaux, France, 33076
- Institut Bergonie; Oncologie
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Bordeaux, France, 33300
- Polyclinique Bordeaux Nord
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Brest, France, 29200
- Hopital Augustin Morvan; Federation De Cancerologie
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Caen, France, 14076
- Centre Francois Baclesse; Recherche Clinique
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Clermont Ferrand, France, 63011
- Centre Jean Perrin; Hopital De Jour
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Dechy, France, 59187
- Centre Leonard De Vinci;Chimiotherapie
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Dijon, France, 21034
- Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
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Grenoble, France, 38000
- Institut Daniel Hollard
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La Roche Sur Yon, France, 85925
- Centre Hospitalier Departemental Les Oudairies
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Le Havre, France, 76600
- Clinique des Ormeaux; Oncologie
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Lille, France, 59020
- Centre Oscar Lambret; Cancerologie Gynecologique
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Limoges, France, 87042
- Hopital Dupuytren; Oncologie Medicale
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Lyon, France, 69373
- Centre Leon Berard; Departement Oncologie Medicale
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Marseille, France, 13273
- Institut Paoli Calmettes; Oncologie Medicale
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Montpellier, France, 34298
- Institut régional du Cancer Montpellier
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Nancy, France, 54100
- Polyclinique De Gentilly; Hemodialyse
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Nice, France, 06189
- Centre Antoine Lacassagne; Hopital De Jour A2
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Nimes, France, 30029
- Institut de cancerologie du Gard
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Paris, France, 75231
- Institut Curie; Oncologie Medicale
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Paris, France, 75651
- Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere
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Perigueux, France, 24000
- Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
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Plerin, France, 22190
- Clinique Armoricaine Radiologie; Hopital de Jour
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Poitiers, France, 86021
- Chu De Poitiers; Chu La Miletrie
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Reims, France, 51056
- Institut Jean Godinot; Hopital De Jour
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Rennes, France, 35042
- Centre Eugene Marquis; Unite Huguenin
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Rouen, France, 76038
- Centre Henri Becquerel; Oncologie Medicale
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Saint Herblain, France, 44805
- Ico Rene Gauducheau; Oncologie
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Saint-Priest en Jarez, France, 42271
- ICL; Hematologie
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St Cloud, France, 92210
- Centre Rene Huguenin; CONSULT SPECIALISEES
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Strasbourg, France, 67010
- Institut d'oncologie de l'Orangerie; Chimiotherapie
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Strasbourg, France, 67098
- Hopital Hautepierre; Hematologie Oncologie
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Toulouse, France, 31059
- Institut Claudius Regaud; Departement Oncologie Medicale
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Toulouse, France, 31076
- Clinique Pasteur; Pneumologie
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Vandoeuvre-les-nancy, France, 54519
- Centre Alexis Vautrin; Oncologie Medicale
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Villejuif, France, 94800
- Institut Gustave Roussy; Oncologie Medicale
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Amberg, Germany, 92224
- Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
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Bad Nauheim, Germany, 61231
- Hochwaldkrankenhaus
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Bergisch Gladbach, Germany, 51465
- Evang. Krankenhaus Frauenklinik
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Berlin, Germany, 14169
- Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
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Berlin, Germany, 10719
- Praxis Dr. Schoenegg
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Berlin, Germany, 10367
- Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
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Berlin, Germany, 13125
- HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
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Bielefeld, Germany, 33604
- Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie
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Bonn, Germany, 53127
- Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde
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Braunschweig, Germany, 38100
- Praxis Dr. Ralf Lorenz
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Bremen, Germany, 28209
- Hämato-Onkologie im Medicum/Home
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Böblingen, Germany, 71032
- Klinikum Sindelfingen-Böblingen; Frauenklinik
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Chemnitz, Germany, 09116
- Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
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Deggendorf, Germany, 94469
- DONAU ISAR Klinikum Deggendorf; Frauenklinik
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Dortmund, Germany, 44137
- St. Johannes-Hospital
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Dresden, Germany, 01307
- Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
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Düsseldorf, Germany, 40225
- Universitätsklinikum Düsseldorf; Frauenklinik
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Düsseldorf, Germany, 40235
- Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
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Erfurt, Germany, 99085
- Praxis fur Hamatologie und Onkologie
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen; Frauenklinik
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Esslingen, Germany, 73730
- Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
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Frankfurt, Germany, 65929
- Städtische Kliniken Frankfurt am Main Höchst
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Frankfurt, Germany, 60596
- Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
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Frankfurt am Main, Germany, 60389
- Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
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Freiburg, Germany, 79110
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
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Fürth, Germany, 90766
- Dres.Jochen Wilke und Harald Wagner
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Greifswald, Germany, 17475
- Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
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Halle, Germany, 06120
- Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
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Hameln, Germany, 31785
- SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum
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Hannover, Germany, 30559
- Diakovere Henriettenstift, Frauenklinik
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Hannover, Germany, 30177
- MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
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Heidelberg, Germany, 69120
- Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
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Hildesheim, Germany, 31134
- Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
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Homburg/Saar, Germany, 66424
- Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
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Karlsruhe, Germany, 76135
- ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
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Kassel, Germany, 34117
- Elisabeth-Krankenhaus Brustzentrum
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Kassel, Germany, 34125
- Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
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Kiel, Germany, 24105
- UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
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Koeln, Germany, 50935
- St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
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Köln, Germany, 50931
- Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
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Landshut, Germany, 84034
- Klinikum Landshut Frauenklinik
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Leipzig, Germany, 04277
- Sankt Elisabeth Krankenhaus; Gynaekology
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Ludwigsfelde, Germany, 14974
- Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
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Mainz, Germany, 55131
- Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
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Muenchen, Germany, 80637
- Rotkreuzklinikum München; Frauenklinik
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Mönchengladbach, Germany, 41061
- Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
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München, Germany, 81675
- Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
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München, Germany, 80336
- Klinikum der Universität München; Frauenklinik - Onkologie II
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Münster, Germany, 48149
- Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
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Offenbach, Germany, 63069
- Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
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Oldenburg, Germany, 26133
- Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
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Ravensburg, Germany, 88212
- Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
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Recklinghausen, Germany, 45659
- Oncologianova GmbH
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Rosenheim, Germany, 83022
- RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe
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Rostock, Germany, 18059
- Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
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Stade, Germany, 21680
- MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
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Trier, Germany, 54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
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Tübingen, Germany, 72076
- Universitätsklinik Tübingen; Frauenklinik
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Ulm, Germany, 89075
- Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
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Velbert, Germany, 42551
- Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
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Villingen-Schwenningen, Germany, 78052
- Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
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Wiesbaden, Germany, 65189
- St. Josefs-Hospital Wiesbaden
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Witten, Germany, 58452
- Marien-Hospital Witten; Frauenklinik Brustzentrum
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Würzburg, Germany, 97080
- Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
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Guatemala, Guatemala, 01010
- Centro Oncológico Sixtino / Centro Oncológico SA
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Guatemala City, Guatemala, 01015
- Grupo Angeles
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Hong Kong, Hong Kong
- Queen Mary Hospital; Dept of Medicine
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Hong Kong, Hong Kong, 852
- Queen Mary Hospital; Surgery
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Budapest, Hungary, 1122
- Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
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Budapest, Hungary, H-1077
- Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
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Budapest, Hungary, 1083
- Semmelweis Egyetem Onkologiai Központ
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Debrecen, Hungary, 4032
- Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
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Gyor, Hungary, 9024
- Petz Aladar Megyei Oktato Korhaz; Oncoradiologia
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Gyula, Hungary, 5703
- Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
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Kecskemet, Hungary, 6000
- Bacs-Kiskun Varmegyei Oktatokorhaz
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Szeged, Hungary, 6720
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
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Veszprem, Hungary, 8200
- Veszprem Megyei Csolnoky; Ferenc Korhaz
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Cork, Ireland
- Cork Uni Hospital; Oncology Dept
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Dublin, Ireland, 7
- Mater Misericordiae Uni Hospital; Oncology
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Dublin, Ireland, 9
- Beaumont Hospital; Cancer Clinical Trials Unit
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Dublin, Ireland, D04 T6F4
- St Vincent'S Uni Hospital; Medical Oncology
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Dublin, Ireland, D08 HNY1
- St. James Hospital; Oncology
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Galway, Ireland, H91YR71
- Galway University Hospital; Clinical Trials Department
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Limerick, Ireland
- University Hospital Limerick - Oncology
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Haifa, Israel, 3109601
- Rambam Medical Center; Oncology
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Petach Tikva, Israel, 4941492
- Rabin MC; Davidof Center - Oncology Institute
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Ramat Gan, Israel, 5262100
- Chaim Sheba Medical Center; Oncology Dept
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Rehovot, Israel, 7610001
- Kaplan Medical Center; Oncology Inst.
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Tel Aviv, Israel, 64239-06
- Sourasky / Ichilov Hospital; Oncology Department
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Calabria
-
Catanzaro, Calabria, Italy, 88100
- Campus Universitario S.Venuta; Centro Oncologico T.Campanella
-
-
Campania
-
Avellino, Campania, Italy, 83100
- AORN'S.G.Moscati; Oncologia
-
Napoli, Campania, Italy, 80131
- IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
-
Napoli, Campania, Italy, 80131
- Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Italy, 40138
- Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
-
Carpi, Emilia-Romagna, Italy, 41012
- Ospedale Ramazzini
-
Reggio Emilia, Emilia-Romagna, Italy, 42100
- Arcispedale Santa Maria Nuova; Oncologia
-
-
Friuli-Venezia Giulia
-
Aviano, Friuli-Venezia Giulia, Italy, 33081
- Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
-
Udine, Friuli-Venezia Giulia, Italy, 33100
- Divisione Onc Med dell'Azienda
-
-
Lazio
-
Viterbo, Lazio, Italy, 01100
- Ospedale Belcolle Di Viterbo; Oncologia
-
-
Liguria
-
Genova, Liguria, Italy, 16132
- IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
-
Genova, Liguria, Italy, 16128
- Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
-
Genova, Liguria, Italy, 16132
- Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
-
-
Lombardia
-
Brescia, Lombardia, Italy, 25123
- ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
-
Lecco, Lombardia, Italy, 23900
- ASST DI LECCO; Oncologia Medica
-
Milano, Lombardia, Italy, 20141
- Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
-
Monza, Lombardia, Italy, 20052
- Policlinico di Monza; Istituto di Oncologia
-
Pavia, Lombardia, Italy, 27100
- IRCCS Fondazione Maugeri; Oncologia Medica I
-
Rozzano (MI), Lombardia, Italy, 20089
- IRCCS Istituto Clinico Humanitas; Oncologia
-
Saronno, Lombardia, Italy, 21047
- Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica
-
-
Marche
-
Fano, Marche, Italy, 61032
- Ospedale S. Croce Di Fano; Servizio Oncologia
-
-
Piemonte
-
Candiolo, Piemonte, Italy, 10060
- Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
-
-
Puglia
-
Brindisi, Puglia, Italy, 72100
- Ospedale Antonio Perrino; Oncologia Medica
-
-
Toscana
-
Prato, Toscana, Italy, 59100
- Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro
-
-
Trentino-Alto Adige
-
Bolzano, Trentino-Alto Adige, Italy, 39100
- Ospedale Di Bolzano; Dept. Di Oncologia
-
-
Umbria
-
Perugia, Umbria, Italy, 06156
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
-
Terni, Umbria, Italy, 05100
- Azienda Ospedaliera S. Maria - Terni; Oncologia
-
-
Veneto
-
Legnago, Veneto, Italy, 37045
- Ospedale Mater Salutis; Dept of Oncology
-
-
-
-
-
Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital, Breast Oncology
-
Chiba, Japan, 277-8577
- National Cancer Center Hospital East
-
Chiba, Japan, 260-8717
- Chiba Cancer Center; Breast Surgical Oncology
-
Ehime, Japan, 791-0280
- Natl Hosp Org Shikoku; Cancer Ctr, Surgery
-
Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center;Breast Oncology
-
Gunma, Japan, 371-8511
- Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery
-
Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
-
Iwate, Japan, 028-3695
- Iwate Med Univ School of Med; Surgery
-
Kagoshima, Japan, 892-0833
- Sagara Hospital; Breast Surgery
-
Kanagawa, Japan, 216-8511
- St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
-
Kanagawa, Japan, 259-1193
- Tokai University Hospital, Breast Surgery
-
Kumamoto, Japan, 862-8505
- Kumamoto City Hospital, Breast and Endocrine Surgery
-
Kumamoto, Japan, 862-8655
- Kumamoto Shinto General Hospital; Breast Cancer Center
-
Kyoto, Japan, 606-8507
- Kyoto University Hospital; Breast Surgery
-
Niigata, Japan, 951-8566
- Niigata Cancer Ctr Hospital; Breast Surgery
-
Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital; Breast Surgery
-
Osaka, Japan, 541-8567
- Osaka International Cancer Institute; Breast and Endocrine Surgery
-
Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center; Breast Oncology
-
Saitama, Japan, 362-0806
- Saitama Cancer Center, Breast Oncology
-
Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center; Breast Surgery
-
Shizuoka, Japan, 420-8527
- Shizuoka General Hospital; Breast Surgery
-
Tochigi, Japan, 329-0498
- Jichi Medical School ; Surgery
-
Tokyo, Japan, 104-0045
- National Cancer Center Hospital; Medical Oncology
-
Tokyo, Japan, 113-8677
- Tokyo Metropolitan; Komagome Hospital, Surgery
-
Tokyo, Japan, 135-8550
- The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
-
Tokyo, Japan, 160-0023
- Tokyo Medical Uni. Hospital; Breast Oncology
-
-
-
-
-
Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
Seoul, Korea, Republic of, 03080
- Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
-
Seoul, Korea, Republic of, 120-752
- Yonsei University Severance Hospital; Medical Oncology
-
Seoul, Korea, Republic of, 136-705
- Korea University Anam Hospital; Oncology Haemotology
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Centre; Division of Hematology/Oncology
-
Seoul, Korea, Republic of, 130-702
- Kyunghee University Hospital; Endocrinology
-
-
-
-
-
Aguascalientes, Mexico, 20230
- Médicos Especialistas en Cáncer SC
-
Durango, Mexico, 34000
- Centro Estatal De Cancerologia De Durango; Oncology
-
San Luis Potosi, Mexico, 78218
- Centro Regional de Enfermedades Oncológicas, S.A.
-
-
Campeche
-
Campehe, Campeche, Mexico, 24096
- Centro Estatal de Oncología de Campeche
-
-
Guanajuato
-
León, Guanajuato, Mexico, 37000
- Fundacion Rodolfo Padilla Padilla A.C.
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44670
- Núcleo de Especialidades Oncológicas
-
-
Mexico CITY (federal District)
-
Mexico City, Mexico CITY (federal District), Mexico, 06760
- Hospital Angeles Metropolitano; Room 220
-
Mexico DF, Mexico CITY (federal District), Mexico, 06726
- Hospital General de México; Unidad de Oncologia
-
-
Nuevo LEON
-
Monterrey, Nuevo LEON, Mexico, 64020
- Centro Universitario Contra El Cancer
-
Montrrey, Nuevo LEON, Mexico, 64710
- Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
-
-
Oaxaca
-
Oaxaca de Juárez, Oaxaca, Mexico, 68000
- Oaxaca Site Management Organization
-
-
Queretaro
-
Queretaro, Queretaro, Queretaro, Mexico, 76090
- Cancerologia de Queretaro; Oncologia
-
-
-
-
-
Alkmaar, Netherlands, 1815 JD
- Medisch Centrum Alkmaar
-
Breda, Netherlands, 4818 CK
- Amphia ziekenhuis, locatie langendijk
-
Delft, Netherlands, 2625 AD
- Reinier de Graaf Gasthuis
-
Maastricht, Netherlands, 6229 HX
- Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
-
Zwolle, Netherlands, 8011 JW
- Isala Klinieken
-
-
-
-
-
Hamilton, New Zealand, 3240
- Waikato Hospital; Dept of Medical Oncology
-
Palmerston North, New Zealand, 4442
- Palmerston North Hospital; Regional Cancer Treatment Service
-
-
-
-
-
Panama, Panama, 0834-02723
- Centro Oncologico America
-
Panama, Panama, 0832-02723
- The Panama Clinic
-
-
-
-
-
Lima, Peru, Lima 34
- Instituto Nacional de Enfermedades Neoplasicas
-
Lima, Peru, L27
- Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
-
San Isidro, Peru, L27 Lima
- Clinica El Golf
-
Trujillo, Peru, 13011
- Clinica Peruana Americana
-
-
-
-
-
Manila, Philippines, 1008
- University Of Santo Tomas; Oncology; Benavides Cancer Institute
-
Pasig City, Philippines, 1605
- Rizal Medical Center
-
Quezon City, Philippines, 1101
- Veterans Memorial Medical Ctr; Cancer Research Centre
-
-
-
-
-
Bialystok, Poland, 15-027
- Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
-
Bydgoszcz, Poland, 85-796
- Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
-
Gdansk, Poland, 80-214
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
-
Opole, Poland, 45-061
- Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
-
Warszawa, Poland, 02-781
- Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
-
Wieliszew, Poland, 05-135
- NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie
-
-
-
-
-
Bucharest, Romania, 050098
- Emergency University Bucharest Hospital; Oncology Department
-
Cluj Napoca, Romania, 400015
- Prof. Dr. I. Chiricuta Institute of Oncology
-
Cluj-Napoca, Romania, 400015
- Oncology Inst. Cluj-Napoca; Cancer Dept
-
Iasi, Romania, 700106
- Euroclinic Center of Oncology SRL
-
-
-
-
-
Samara, Russian Federation, 443031
- SBI of Healthcare Samara Regional Clinical Oncology Dispensary
-
Stavropol, Russian Federation, 355045
- SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
-
Tula, Russian Federation, 300053
- Tula Regional Oncology Dispensary
-
-
Moskovskaja Oblast
-
Moscow, Moskovskaja Oblast, Russian Federation, 115478
- S.I. Russian Oncological Research Center n.a. N.N. Blokhin
-
-
Stavropol
-
Pyatigorsk, Stavropol, Russian Federation, 357502
- State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
-
-
Tatarstan
-
Kazan, Tatarstan, Russian Federation, 420029
- Clinical Oncology Dispensary of Ministry of Health of Tatarstan
-
-
-
-
-
Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
-
-
-
-
-
Bloemfontein, South Africa, 9301
- National Hospital; Oncotherapy Dept
-
Johannesburg, South Africa, 2193
- Wits Donald Gordon Clinical Trial Centre; Medical Oncology
-
Pretoria, South Africa, 0002
- Steve Biko Academic Hospital; Oncology
-
-
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar; Servicio de Oncologia
-
Barcelona, Spain, 08907
- Hospital Duran i Reynals; Oncologia
-
Barcelona, Spain, 08036
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
-
Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
-
Huelva, Spain, 21005
- Hospital Juan Ramon Jimenez;Servicio de Oncologia
-
Jaen, Spain, 23007
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
-
La Coruña, Spain, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
-
La Coruña, Spain, 15009
- Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
-
Lerida, Spain, 25198
- Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
-
Madrid, Spain, 28034
- Hospital Ramon y Cajal; Servicio de Oncologia
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
-
Madrid, Spain, 28040
- Hospital Universitario Clínico San Carlos; Servicio de Oncologia
-
Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
-
Madrid, Spain, 28033
- Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
-
Madrid, Spain, 28050
- Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
-
Malaga, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
-
Murcia, Spain, 30008
- Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
-
Salamanca, Spain, 37007
- Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
-
Sevilla, Spain, 41014
- Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
-
Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena; Servicio de Oncologia
-
Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio; Servicio de Oncologia
-
Toledo, Spain, 45004
- Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
-
Valencia, Spain, 46009
- Instituto Valenciano Oncologia; Oncologia Medica
-
Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
-
Valencia, Spain, 46015
- Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
-
Valencia, Spain, 46026
- Hospital Universitario la Fe; Servicio de Oncologia
-
Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet; Servicio Oncologia
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- Hospital General Universitario de Elche; Servicio de Oncologia
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
-
Sabadell, Barcelona, Spain, 8208
- Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
-
Sant Andreu de La Barca, Barcelona, Spain, 08740
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
-
-
Castellon
-
Castellon de La Plana, Castellon, Spain, 12002
- Hospital Provincial de Castellon; Servicio de Oncologia
-
-
Cordoba
-
Córdoba, Cordoba, Spain, 14004
- Hospital Universitario Reina Sofia; Servicio de Oncologia
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, Spain, 20080
- Hospital de Donostia; Servicio de Oncologia Medica
-
San Sebastian, Guipuzcoa, Spain, 20014
- IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
-
-
Islas Baleares
-
Palma De Mallorca, Islas Baleares, Spain, 07014
- Hospital Universitario Son Espases
-
Palma de Mallorca, Islas Baleares, Spain, 07198
- Hospital Son Llatzer; Servicio de Oncologia
-
-
LA Coruña
-
Santiago de Compostela, LA Coruña, Spain, 15706
- Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
-
-
Tenerife
-
La Laguna, Tenerife, Spain, 38320
- Hospital Universitario de Canarias;servicio de Oncologia
-
-
-
-
-
Gothenburg, Sweden, 41 343
- Sahlgrenska Universitetssjukhuset; Onkology
-
Linköping, Sweden, 58185
- Uni Hospital Linkoeping; Dept. of Oncology
-
Stockholm, Sweden, 11883
- Karolinska University Hospital; Department of General Oncology
-
Umea, Sweden, 90185
- Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology
-
Uppsala, Sweden, 751 85
- Akademiska sjukhuset, Onkologkliniken
-
-
-
-
-
Basel, Switzerland, 4031
- Universitaetsspital Basel; Onkologie
-
Genève 14, Switzerland, 1211
- Hôpitaux Universit. de Genève Gynécologique - Oncologie; Gynécologie
-
Luzern, Switzerland, 6004
- Luzerner Kantonsspital; Medizinische Onkologie
-
St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen; Onkologie/Hämatologie
-
Zürich, Switzerland, 8008
- Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
-
-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital; Dept of Surgery
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
-
Taichung, Taiwan, 407
- Taichung Veterans General Hospital; Dept of Surgery
-
Tainan, Taiwan, 704
- National Cheng Kung Uni Hospital; Surgery
-
Taipei, Taiwan, 00112
- VETERANS GENERAL HOSPITAL; Department of General Surgery
-
Taipei, Taiwan, 100
- National Taiwan Uni Hospital; General Surgery
-
Taipei, Taiwan, 114
- Tri-Service General Hospital, Division of General Surgery
-
-
-
-
-
Chiang Rai, Thailand, 57000
- Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine
-
Lopburi, Thailand, 15000
- Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy
-
Phitsanuok, Thailand, 65000
- Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine
-
Songkla, Thailand, 90110
- Songklanagarind Hospital; Department of Surgery
-
Surat Thani, Thailand, 84000
- Surat Thani Hospital
-
-
-
-
-
Cherkassy, Ukraine, 18009
- Cherkassy Regional Oncological Hospital
-
Dnipropetrovsk, Ukraine, 43102
- State Medical Academy; Oncology
-
Ivano-Frankivsk, Ukraine, 76018
- Ivano-Frankivsk Regional Oncology Center
-
Kiev, Ukraine, 03115
- Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
-
Lutsk, Ukraine, 43018
- Volyn Regional Oncology Dispensary
-
Lvov, Ukraine, 79031
- Lvov State Regional Oncology Medical & Diagnostic Center
-
Ternopil, Ukraine, 46023
- Ternopil State Medical Academy
-
-
-
-
-
Berkshire, United Kingdom, RG1 5AN
- Royal Berkshire Hospital; Berkshire Cancer Centre
-
Cardiff, United Kingdom, CF14 2TL
- Velindre Cancer Centre; Oncology Dept
-
Cheltenham, United Kingdom, GL53 7AN
- Cheltenham General Hospital; Gloucestershire Oncology Centre
-
Colchester, Essex, United Kingdom, CO4 5JL
- Colchester General Hospital
-
Cornwall, United Kingdom, TR1 3LQ
- Royal Cornwall Hospital; Dept of Clinical Oncology
-
Coventry, United Kingdom, CV2 2DX
- University Hospital coventry; Oncology Department
-
Edinburgh, United Kingdom, EH4 2XU
- Western General Hospital; Edinburgh Breast Unit
-
Exeter, United Kingdom, EX2 5DW
- Royal Devon & Exeter Hospital; Oncology Centre
-
Ipswich, United Kingdom, IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
-
Leeds, United Kingdom, LS9 7TF
- St James Uni Hospital; Icrf Cancer Medicine Research Unit
-
London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital; Dept of Med-Onc
-
London, United Kingdom, EC1A 7BE
- St. Bartholomew'S Hospital; Dept of Medical Oncology
-
London, United Kingdom, NW1 2PG
- UCL Hospital NHS Trust
-
Manchester, United Kingdom, M20 4QL
- Christie Hospital; Breast Cancer Research Office
-
Northwood, United Kingdom, HA6 2RN
- Mount Vernon Hospital; Centre For Cancer Treatment
-
Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital; Oncology
-
Oxford, United Kingdom, OX3 7LJ
- Churchill Hospital; Oxford Cancer and Haematology Centre
-
Peterborough, United Kingdom, PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
-
Portsmouth, United Kingdom, PO6 3LY
- Queen Alexandra Hospital; Haematology and Oncology Centre
-
Preston, United Kingdom, PR2 9HT
- Royal Preston Hosp; Rosemere Cancer Ctr
-
Sheffield, United Kingdom, S10 2SJ
- Weston Park Hospital; Cancer Clinical Trials Centre
-
Stoke-on-Trent, United Kingdom, ST4 6QG
- Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
-
Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit
-
Wirral, United Kingdom, CH63 4JY
- The Clatterbridge Cancer Ctr For Oncolgy
-
Wolverhampton, United Kingdom, WV10 0QP
- New Cross Hospital; Deansley Centre
-
-
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- HonorHealth Research Institute ? Bisgrove
-
-
California
-
Everett, California, United States, 98208
- Providence Regional Medical Center
-
Greenbrae, California, United States, 94904
- Marin Cancer Care Inc
-
Hayward, California, United States, 94545
- Kaiser Permanente - Hayward
-
La Jolla, California, United States, 92093
- UCSD Moores Cancer Center
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
Oakland, California, United States, 94611
- Kaiser Permanente - Oakland
-
Roseville, California, United States, 95661
- Kaiser Permanente - Roseville
-
Sacramento, California, United States, 95816
- Sutter Cancer Center
-
Sacramento, California, United States, 95825
- Kaiser Permanente Sacramento Medical Center
-
San Diego, California, United States, 92108
- Southern California Kaiser Permanente
-
San Francisco, California, United States, 94115
- K. Permanente - San Fransisco
-
San Jose, California, United States, 95119
- K. Permanente - San Jose
-
Santa Clara, California, United States, 95051
- K. Permanente - Santa Clara
-
South San Francisco, California, United States, 94080
- K. Permanente - S. San Fran
-
Vallejo, California, United States, 94589
- Kaiser Permanente; Oncology Clinical Trials
-
Walnut Creek, California, United States, 94596
- K. Permanente - Walnut Creek
-
-
Colorado
-
Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Center - Denver
-
Wheat Ridge, Colorado, United States, 80033
- Lutheran Hematology &Oncology
-
-
Connecticut
-
Norwich, Connecticut, United States, 06360
- Eastern Ct Hema/Onco Assoc; Dept of Oncology
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Washington Cancer Institute at MedStar Washington Hospital Center.
-
Washington, District of Columbia, United States, 20016-1468
- Georgetown U; Lombardi Comp Can
-
-
Florida
-
Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists; SCRI
-
Hollywood, Florida, United States, 33021
- Memorial Cancer Institute
-
Jacksonville, Florida, United States, 32256
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic-Jacksonville
-
Ocala, Florida, United States, 34471
- Ocala Oncology Center
-
Pembroke Pines, Florida, United States, 33028-1006
- Memorial Breast Cancer Center
-
Port Saint Lucie, Florida, United States, 34952
- Hematology Oncology Associates of the Treasure Coast
-
Saint Petersburg, Florida, United States, 33719
- Florida Cancer Specialists; Saint Petersburg
-
West Palm Beach, Florida, United States, 33401
- Florida Cancer Specialists, Research Department
-
-
Georgia
-
Albany, Georgia, United States, 31701
- Phoebe Putney Memorial Hospital
-
Atlanta, Georgia, United States, 30341
- Georgia Cancer Specialists
-
Marietta, Georgia, United States, 30060
- Northwest Georgia Oncology Centers PC - Marietta
-
-
Idaho
-
Post Falls, Idaho, United States, 83854
- Kootenai Cancer Center
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
Chicago, Illinois, United States, 60637
- Uni of Chicago
-
Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
-
Maywood, Illinois, United States, 60153
- Loyola University Med Center
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Naperville, Illinois, United States, 60540
- Edward Cancer Center Naperville
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Peoria, Illinois, United States, 61615
- Illinois Cancer Care
-
Plainfield, Illinois, United States, 60585
- Edward Cancer Center Plainfield
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Quincy, Illinois, United States, 62301
- Quincy Medical Group; Canc Ctr at Blessing Hosp
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Urbana, Illinois, United States, 61801
- Carle Foundation
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Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
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Kansas
-
Wichita, Kansas, United States, 67214-3728
- Cancer Center of Kansas
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Louisiana
-
Lafayette, Louisiana, United States, 70506
- Cancer Center of Acadiana at Lafayette General
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Maine
-
Brewer, Maine, United States, 04412
- Cancer Care of Maine
-
Scarborough, Maine, United States, 04074
- New England Cancer Specialists
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Maryland
-
Baltimore, Maryland, United States, 21202
- Mercy Medical Center
-
Baltimore, Maryland, United States, 21237
- Weinberg CA Inst Franklin Sq
-
Bethesda, Maryland, United States, 20817
- Maryland Oncology & Hematology, PA
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Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Boston, Massachusetts, United States, 02215
- Dana Farber Can Ins
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital.
-
Boston, Massachusetts, United States, 02130
- Dana Farber Cancer Institute at Faulkner Hospital
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Boston, Massachusetts, United States, 02215
- Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy
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Pittsfield, Massachusetts, United States, 01201
- Berkshire Hematology, Oncology Pc
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Michigan
-
Grand Rapids, Michigan, United States, 49503
- Grand Rapids Clinical Oncology Program
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Minnesota
-
Edina, Minnesota, United States, 55414
- Southdale Cancer Clinic
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Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- Metro-Minnesota Community Oncology Research Consortium
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Mississippi
-
Jackson, Mississippi, United States, 39202
- Jackson Oncology Associates, PLLC
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Missouri
-
Kansas City, Missouri, United States, 64108
- University of Missouri-Columbia; Ellis Fischel Cancer Center
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63131
- Heartland CCOP/Missouri Baptist Medical Center
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Nebraska
-
Lincoln, Nebraska, United States, 68510
- Cancer Alliance of Nebraska
-
Omaha, Nebraska, United States, 68106
- Cancer Alliance of Nebraska
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New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Med Center
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New Jersey
-
Livingston, New Jersey, United States, 07039
- Saint Barnabas Medical Center
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New York
-
Albany, New York, United States, 12206
- New York Oncology Hematology, P.C.
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Inst.
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10019
- Mount Sinai West
-
New York, New York, United States, 10011
- Mount Sinai Beth Israel Comprehensive Cancer Center
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New York, New York, United States, 10003
- Mount Sinai Beth Israel Medical Center
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina-Chapel Hill
-
Hickory, North Carolina, United States, 28602
- Carolina Oncology Specialists, PA - Hickory
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Ohio
-
Centerville, Ohio, United States, 45459
- Dayton Clinical Oncology Prog
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care Inc
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Columbus, Ohio, United States, 43219
- The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
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Toledo, Ohio, United States, 43623-3536
- Toledo Clinic Cancer Center
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Oregon
-
Portland, Oregon, United States, 97213
- Northwest Cancer Specialists - Portland (NE Hoyt St)
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center; Univ of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Healthcare Network ; Cancer Center
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Pittsburgh, Pennsylvania, United States, 15213
- Magee Womens Hospital
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South Carolina
-
Charleston, South Carolina, United States, 29414
- Charleston Oncology, P .A
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Charleston, South Carolina, United States, 29414
- Roper Bon Secours St. Francis Cancer Center
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Columbia, South Carolina, United States, 29210
- South Carolina Oncology Associates - SCRI
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Greenville, South Carolina, United States, 29615
- Cancer Centers of the Carolina; Eastside Medical Center
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South Dakota
-
Sioux Falls, South Dakota, United States, 57104
- Sanford USD School of Medicine
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Tennessee
-
Chattanooga, Tennessee, United States, 37404
- Tennessee Oncology , PLLC - Chattanooga
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Nashville, Tennessee, United States, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Nashville, Tennessee, United States, 37203
- Tennessee Onc., PLLC - SCRI
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Texas
-
Dallas, Texas, United States, 75230
- Texas Oncology-Medical City Dallas
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Dallas, Texas, United States, 75246
- Texas Oncology - DFW
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Dallas, Texas, United States, 75231
- Texas Oncology - DFW at Dallas Presbyterian Hospital
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El Paso, Texas, United States, 79902
- Texas Oncology-El Paso Cancer Treatment Center Grandview
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Fort Worth, Texas, United States, 76104
- The Center for Cancer and Blood Disorders - Fort Worth
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Fort Worth, Texas, United States, 76104
- Texas Oncology - DFW Fort Worth
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Garland, Texas, United States, 77060
- Texas Oncology, P.A. - Garland
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Houston, Texas, United States, 77024
- Texas Oncology - Houston (Gessner)
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Irving, Texas, United States, 75063
- Texas Oncology-Tyler
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New Braunfels, Texas, United States, 78130
- Cancer Care Centers of South Texas-HOAST - San Antonio
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Plano, Texas, United States, 75075
- Texas Oncology - DFW Plano
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Utah
-
Ogden, Utah, United States, 84405
- Community Cancer Trials of Utah
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Virginia
-
Bristol, Virginia, United States, 24201
- Wellmonth Physician Services
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Richmond, Virginia, United States, 23229
- Virginia Cancer Institute
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Washington
-
Walla Walla, Washington, United States, 99362
- Providence St. Mary Regional Cancer Center
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West Virginia
-
Morgantown, West Virginia, United States, 26056
- West Virginia University Hospitals Inc
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- Green Bay Oncology/St. Mary?s Hospital
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pertuzumab + Trastuzumab + Chemotherapy
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).
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Doxorubicin will be administered as per the schedule specified in the respective arm.
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Paclitaxel will be administered as per the schedule specified in the respective arm.
Trastuzumab will be administered as per the schedule specified in the respective arm.
Other Names:
Pertuzumab will be administered as per the schedule specified in the respective arm.
Other Names:
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Carboplatin will be administered as per the schedule specified in the respective arm.
Docetaxel will be administered as per the schedule specified in the respective arm.
Epirubicin will be administered as per the schedule specified in the respective arm.
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Placebo Comparator: Placebo + Trastuzumab + Chemotherapy
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]).
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Doxorubicin will be administered as per the schedule specified in the respective arm.
Cyclophosphamide will be administered as per the schedule specified in the respective arm.
Paclitaxel will be administered as per the schedule specified in the respective arm.
Trastuzumab will be administered as per the schedule specified in the respective arm.
Other Names:
Placebo will be administered as per the schedule specified in the respective arm.
5-Fluorouracil will be administered as per the schedule specified in the respective arm.
Carboplatin will be administered as per the schedule specified in the respective arm.
Docetaxel will be administered as per the schedule specified in the respective arm.
Epirubicin will be administered as per the schedule specified in the respective arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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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.
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Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: 3 years
|
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 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.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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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).
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Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: 3 years
|
Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 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).
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3 years
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Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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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.
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Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: 3 years
|
Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 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.
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3 years
|
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Percentage of Participants Who Died
Time Frame: Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Percentage of participants who died due to any cause is reported.
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Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3
Time Frame: 3 years
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The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.
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3 years
|
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Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Percentage of participants with RFI event is reported.
RFI event was defined as local, regional or distant breast cancer recurrence.
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Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
|
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Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: 3 years
|
Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported.
RFI event was defined as local, regional or distant breast cancer recurrence.
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3 years
|
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Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Percentage of participants with DRFI event is reported.
DRFI event was defined as distant breast cancer recurrence.
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Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)
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Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
Time Frame: 3 years
|
Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported.
DRFI event was defined as distant breast cancer recurrence.
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3 years
|
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Percentage of Participants With Primary Cardiac Event
Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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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.
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Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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Percentage of Participants With Secondary Cardiac Event
Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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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).
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Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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Change From Baseline in LVEF to Worst Post-Baseline Value
Time Frame: Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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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.
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Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)
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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
Time Frame: 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
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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.
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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
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Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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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.
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Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
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Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
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Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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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.
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Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
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Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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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.
|
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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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.
|
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
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
|
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
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
|
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
Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
|
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.
|
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
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|
Trough Serum Concentration (Cmin) of Pertuzumab
Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)
|
Cycles 1, 10 and 15 (Cycle length=21 days)
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Cmin of Trastuzumab
Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)
|
Cycles 1, 10 and 15 (Cycle length=21 days)
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|
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Peak Serum Concentration (Cmax) of Pertuzumab
Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)
|
Cycles 1, 10 and 15 (Cycle length=21 days)
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Cmax of Trastuzumab
Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)
|
Cycles 1, 10 and 15 (Cycle length=21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gelber 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.
- Bines 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.
- Piccart 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.
- Bines 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.
- Luo 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.
- Kirschbrown 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.
- von 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. Erratum In: N Engl J Med. 2017 Aug 17;377(7):702. N Engl J Med. 2018 Oct 18;379(16):1585.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2011
Primary Completion (Actual)
December 19, 2016
Study Completion (Estimated)
November 28, 2024
Study Registration Dates
First Submitted
May 20, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimated)
May 24, 2011
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Carboplatin
- Paclitaxel
- Trastuzumab
- Fluorouracil
- Epirubicin
- Doxorubicin
- Pertuzumab
Other Study ID Numbers
- BO25126
- TOC4939G (Other Identifier: Genentech)
- 2010-022902-41 (EudraCT Number)
- BIG 4-11 (Other Identifier: Breast International Group)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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