Breast Cancer Clinical Trial

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Summary

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult patient, >/= 18 years of age
HER2-positive breast cancer
Histologically confirmed invasive breast carcinoma
Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
An interval of no more than 12 weeks between the date of surgery and the date of randomization
Known hormone-receptor status
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic, renal and liver function
Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug
Documentation of hepatitis B virus and hepatitis C virus serology is required

Exclusion Criteria:

Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
Progressive disease during preoperative systemic therapy
Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
Cardiopulmonary dysfunction as defined by protocol
Prior treatment with trastuzumab emtansine
Current severe, uncontrolled systemic disease
Pregnant or lactating women
Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1487

Study ID:

NCT01772472

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 264 Locations for this study

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Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach California, 90806, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange California, 92868, United States
Stanford University Medical Center
Palo Alto California, 94304, United States
Kaiser Permanente - San Diego
San Diego California, 92120, United States
Breastlink Medical Group Inc
Santa Ana California, 92705, United States
Kaiser Permanente - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente - Franklin
Denver Colorado, 80205, United States
Colorado Cancer Research Program/Admin
Denver Colorado, 80222, United States
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
Lone Tree Colorado, 80124, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Washington Cancer Institute; Washington Hospital Center
Washington District of Columbia, 20010, United States
University of Florida; Davis Cancer Pavilion and Shands Medical Plaza
Gainesville Florida, 32610, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
UF Health Orlando
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Edward Cancer Center Naperville
Naperville Illinois, 60540, United States
Edward Cancer Center Plainfield
Plainfield Illinois, 60585, United States
University of Iowa
Lowa City Iowa, 52242, United States
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States
Norton Healthcare Inc.
Louisville Kentucky, 40202, United States
Cancer Care of Maine
Brewer Maine, 04412, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Mercy Medical Center; Medical Oncology & Hematology
Baltimore Maryland, 21202, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Med Star Franklin Square Medical Center/Weinburg Cancer Institute
Baltimore Maryland, 21237, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Spectrum Health Hospitals
Grand Rapids Michigan, 49503, United States
Breslin Cancer Center
Lansing Michigan, 48910, United States
William Beaumont Hospital
Royal Oak Michigan, 48073, United States
US oncology research at Minnesota Oncology
Saint Paul Minnesota, 55102, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Sparta Cancer Center
Sparta New Jersey, 07871, United States
Columbia University Medical Center
New York New York, 10032, United States
Troy Cancer Treatment Program
Troy New York, 12180, United States
Carolinas Medical Center
Charlotte North Carolina, 28204, United States
Batte Cancer Center - Carolinas Medical Center
Concord North Carolina, 28025, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58102, United States
Aultman Hospital; Aultman Hospital Cancer Center
Canton Ohio, 44710, United States
Fairview Hospital; Cleveland Clinic Cancer Center
Cleveland Ohio, 44111, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University, Arthur James Cancer Hospital
Columbus Ohio, 43210, United States
Lake Health/University Hospitals - Mentor Campus
Mentor Ohio, 44060, United States
Columbia River Oncology Program
Portland Oregon, 97213, United States
Kimmel Cancer Center Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Allegheny Cancer Center
Pittsburgh Pennsylvania, 15212, United States
Uni of Pittsburgh; Magee-Women'S Hospital
Pittsburgh Pennsylvania, 15213, United States
York Hospital
York Pennsylvania, 17403, United States
Medical University of South Carolina; Hollings Cancer Center
Charleston South Carolina, 29425, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Houston Methodist Hospital Outpatient Center
Houston Texas, 77030, United States
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
Houston Texas, 77030, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock Texas, 79410, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg Virginia, 22408, United States
Lynchburg Hem Onc Clinic Inc
Lynchburg Virginia, 24501, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond Virginia, 23298, United States
Swedish Cancer Institute - Issaquah
Issaquah Washington, 98029, United States
PeaceHealth St. John Medical Center - Lower Columbia Cancer Center
Longview Washington, 98632, United States
Cancer Care Northwest
Spokane Washington, 99204, United States
Marshfield Clinic
Marshfield Wisconsin, 54449, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
Instituto de Oncología de Rosario
Rosario , S2000, Argentina
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck , 6020, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg , 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Wien , 1090, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien , 1090, Austria
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
AZ Sint Lucas (Sint Lucas)
Gent , 9000, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Iop Instituto de Oncologia Do Parana
Curitiba PR, 80530, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro RJ, 20560, Brazil
Clinicas Oncologicas Integradas - COI
Rio De Janeiro RJ, 22290, Brazil
UPCO - Unidade de Pesquisas Clínicas em Oncologia
Pelotas RS, 96020, Brazil
Hospital Moinhos de Vento
Porto Alegre RS, 90035, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 90040, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
Sao Paulo SP, 01236, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Hospital Perola Byington
Sao Paulo SP, 01317, Brazil
Hospital Sao Jose
Sao Paulo SP, 01321, Brazil
Tom Baker Cancer Centre; Dept of Medicine
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton Alberta, T6G 1, Canada
BC Cancer ? Surrey
Surrey British Columbia, V3V 1, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
London Regional Cancer Centre
London Ontario, N6A 4, Canada
The Ottawa Hospital; Division of Infectious Diseases
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
CSSS champlain - Charles-Le Moyne
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal Quebec, H2X 0, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
McGill University Health Centre - Glen Site
Montreal Quebec, H4A 3, Canada
Hopital du Saint Sacrement
Quebec City Quebec, G1S 4, Canada
the First Hospital of Jilin University
Changchun , 13002, China
Sun Yet-sen University Cancer Center
Guangzhou City , 51066, China
Guangdong General Hospital
Guangzhou , 51008, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Shandong Cancer Hospital
Jinan , 25011, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai , 20002, China
Clinica del Country
Bogota , 11001, Colombia
Hospital Pablo Tobon Uribe
Medellin , 05003, Colombia
Oncomedica S.A.
Monteria , 23000, Colombia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc , 779 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Institut Sainte Catherine;Recherche Clinique
Avignon , 84918, France
HOPITAL JEAN MINJOZ; Oncologie
Besancon , 25030, France
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg En Bresse , 01012, France
Centre Francois Baclesse; Comite Sein
Caen , 14076, France
Centre Jean Perrin; Oncologie
Clermont Ferrand , 63011, France
Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH
Le Mans , 72000, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille , 13273, France
Centre Val Aurelle Paul Lamarque; Recherche Clinique
Montpellier , 34298, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
Hopital Saint Louis; Oncologie Medicale
Paris , 75475, France
HOPITAL TENON; Cancerologie Medicale
Paris , 75970, France
Centre Henri Becquerel; Oncologie Medicale
Rouen , 76038, France
Centre Rene Huguenin; CONSULT SPECIALISEES
St Cloud , 92210, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg , 67065, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Hämatologie Onkologie im Zentrum MVZ GmbH
Augsburg , 86150, Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Berlin , 10367, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin , 10707, Germany
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
Berlin , 13125, Germany
Studienzentrum Berlin City
Berlin , 14169, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld , 33604, Germany
Klinikum Sindelfingen-Böblingen; Frauenklinik
Böblingen , 71032, Germany
St. Johannes-Hospital
Dortmund , 44137, Germany
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
Düsseldorf , 40235, Germany
Universitätsklinikum Erlangen; Frauenklinik
Erlangen , 91054, Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen , 45122, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen , 45136, Germany
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
Esslingen , 73730, Germany
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main , 60389, Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
Frankfurt , 60596, Germany
Universitätsklinikum Freiburg; Frauenklinik
Freiburg , 79106, Germany
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
Gelsenkirchen , 45879, Germany
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
Greifswald , 17475, Germany
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
Halle , 06110, Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle , 06120, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg , 20357, Germany
St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik
Hamm , 59073, Germany
MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
Hannover , 30177, Germany
Diakovere Henriettenstift, Frauenklinik
Hannover , 30559, Germany
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hannover , 30625, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg , 69120, Germany
Elisabeth-Krankenhaus Brustzentrum
Kassel , 34117, Germany
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
Kassel , 34125, Germany
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel , 24105, Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Koeln , 50935, Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
Köln , 51067, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel
Lebach , 66822, Germany
Klinikum der Universität München; Frauenklinik - Onkologie II
München , 80336, Germany
Medizinisches Zentrum für Hämatologie und Onkologie
München , 80639, Germany
MVZ Nordhausen gGmbH, Praxis Dr. Grafe
Nordhausen , 99734, Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach , 63069, Germany
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
Paderborn , 33098, Germany
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
Recklinghausen , 45659, Germany
Klinikum am Steinenberg Frauenklinik
Reutlingen , 72764, Germany
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
Rostock , 18059, Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund , 18439, Germany
Robert-Bosch-Krankenhaus; Brustzentrum
Stuttgart , 70376, Germany
Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung
Traunstein , 83278, Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen , 72076, Germany
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
Ulm , 89075, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
Wiesbaden , 65199, Germany
Marien-Hospital Witten; Frauenklinik Brustzentrum
Witten , 58452, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg , 97080, Germany
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki , 546 4, Greece
Grupo Angeles
Guatemala City , 01015, Guatemala
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala , 01010, Guatemala
Queen Mary Hospital; Surgery
Hong Kong , 852, Hong Kong
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Tuen Mun Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Cork Uni Hospital; Oncology Dept
Cork , , Ireland
Mater Misericordiae Uni Hospital; Oncology
Dublin , 7, Ireland
Beaumont Hospital; Cancer Clinical Trials Unit
Dublin , 9, Ireland
St Vincent'S Uni Hospital; Medical Oncology
Dublin , D04 T, Ireland
Galway Uni Hospital; Oncology Dept
Galway , , Ireland
University Hospital Limerick - Oncology
Limerick , , Ireland
Soroka Medical Center
Beer Sheva , 84101, Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem , 91031, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Sheba Medical Center; Tel Hashomer
Ramat Gan , 52621, Israel
Kaplan Medical Center; Oncology Inst.
Rehovot , 76100, Israel
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli Campania, 80131, Italy
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii
Bologna Emilia-Romagna, 40138, Italy
Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
Bologna Emilia-Romagna, 40139, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma Lazio, 00128, Italy
Az. Osp. Sant'Andrea; Oncologia Medica
Roma Lazio, 00189, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genova Liguria, 16132, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo Lombardia, 24127, Italy
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona Lombardia, 26100, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano Lombardia, 20133, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
ASST DI MONZA; Oncologia Medica
Monza Lombardia, 20900, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo Piemonte, 10060, Italy
Ospedale Antonio Perrino; Oncologia Medica
Brindisi Puglia, 72100, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa Toscana, 56100, Italy
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
Pontedera Toscana, 56025, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
Verona Veneto, 37126, Italy
Hospital Angeles Metropolitano; Room 220
Mexico City Mexico CITY (federal District), 06760, Mexico
Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir
Mexico City Mexico CITY (federal District), 14080, Mexico
Oaxaca Site Management Organization
Oaxaca de Juárez Oaxaca, 68000, Mexico
Médicos Especialistas en Cáncer SC
Aguascalientes , 20230, Mexico
Instituto Nacional de Cancerologia; Oncology
Mexico City , 14080, Mexico
The Panama Clinic
Panama , 0832, Panama
Centro Oncologico America
Panama , 0834-, Panama
Centro Medico Monte Carmelo
Arequipa , 04001, Peru
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa , 04001, Peru
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista , Calla, Peru
Hospital Nacional Guillermo Almenara Irigoyen; Oncology
Lima , 13, Peru
Clinica San Borja
Lima , Lima , Peru
Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology
Belgrade , 11000, Serbia
Oncology Institute of Vojvodina
Sremska Kamenica , 21204, Serbia
Cape Town Oncology Trials
Cape Town , 7570, South Africa
Hopelands Cancer Centre
Hilton , 3245, South Africa
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Johannesburg , 2193, South Africa
Medical Oncology Centre of Rosebank; Oncology
Johannesburg , 2196, South Africa
Cancercare
Port Elizabeth , 6045, South Africa
Private Oncology Centre
Pretoria , 0081, South Africa
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian Guipuzcoa, 20080, Spain
Hospital Severo Ochoa; Servicio de Oncologia
Leganes Madrid, 28911, Spain
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
Vigo Pontevedra, 36312, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus Tarragona, 43204, Spain
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona , 08036, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid , 28050, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29011, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra , 31008, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia , 46009, Spain
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia , 46017, Spain
Gävle Sjukhus; Onkologiska Kliniken
Gävle , 80187, Sweden
Skånes University Hospital, Skånes Department of Onclology
Lund , 221 8, Sweden
Karolinska Hospital; Oncology - Radiumhemmet
Stockholm , 171 7, Sweden
Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN
Aarau , 5001, Switzerland
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Zürich , 8008, Switzerland
Taichung Veterans General Hospital; Dept of Surgery
Taichung , 407, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei City , 11259, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei , 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei , 100, Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery
Taoyuan , 333, Taiwan
Uludag Uni Hospital; Oncology
Bursa , 16059, Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne , 22770, Turkey
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
Istanbul , 34865, Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir , 35100, Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya , 44280, Turkey
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford , BD9 6, United Kingdom
Bristol Haematology and Oncology centre
Bristol , BS2 8, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall , TR1 3, United Kingdom
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
Cottingham , HU16 , United Kingdom
North Devon District Hospital
Devon , EX31 , United Kingdom
Ninewells Hospital; Cancer Medicine
Dundee , DD1 9, United Kingdom
Huddersfield Royal Infirmary
Huddersfield , HD3 3, United Kingdom
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
Leeds , LS9 7, United Kingdom
St Thomas Hospital; Medicine Div.
London , SE1 7, United Kingdom
Charing Cross Hospital; Medical Oncology.
London , W6 8R, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Nottingham City Hospital; Oncology
Nottingham , NG5 1, United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1487

Study ID:

NCT01772472

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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