Spots Global Cancer Trial Database for A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
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Trial Identification
Brief Title: A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
Official Title: A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)
Study ID: NCT01026142
Conditions
Study Description
Brief Summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Fundación Investigar, Buenos Aires, , Argentina
Hospital Britanico; Oncologia, Buenos Aires, , Argentina
Instituto FIDES, La Plata, , Argentina
Instituto de Investigaciones Clínicas Quilmes, Quilmes, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med., Krems, , Austria
Landeskrankenhaus Rankweil; Interne E, Rankweil, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Wien, , Austria
Imeldaziekenhuis, Bonheiden, , Belgium
AZ KLINA, Brasschaat, , Belgium
UZ Brussel, Brussel, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Clinique Saint-Joseph, Liège, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
AZ Nikolaas (Lodewijk), Sint-Niklaas, , Belgium
Oncologia Sul Capixaba Servicos Medicos - Oncosul, Cachoeiro Do Itapemirim, ES, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil
Centro Oncológico de Mogi das Cruzes, São Paulo- SP, SP, Brazil
Durham Regional Cancer Centre, Oshawa, Ontario, Canada
Humber River Hospital, Toronto, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
Uni Hospital For Tumours; Dept of Medical Oncology, Zagreb, , Croatia
Masarykuv onkologicky ustav; Oncology II, Brno, , Czechia
University Hospital; Oncology and Radiotherapy, Hradec Kralove, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Praha 2, , Czechia
Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie, Praha, , Czechia
North Estonia Medical Centre Foundation; Oncology Centre, Tallinn, , Estonia
Tartu University Hospital; Clinic of Hematology and Oncology, Tartu, , Estonia
C.H. Du Pays D'aix En Provence Service du Dr Blanc, Aix En Provence, , France
Centre Oncologie Du Pays Basque, Bayonne, , France
Centre Hospitalier Fleyriat; Oncologie/Hematologie, Bourg En Bresse, , France
CHU Henri Mondor; Service d'Oncologie Medicale, Creteil, , France
Centre Georges Francois Leclerc; Oncologie 3, Dijon, , France
Centre Leon Berard; Oncologie Genetique, Lyon, , France
Centre Antoine Lacassagne; Hopital De Jour A2, Nice, , France
Institut Curie; Oncologie Medicale, Paris, , France
Hopital Saint Antoine; Sce Oncologie, Paris, , France
Institut Jean Godinot; Oncologie Medicale, Reims CEDEX, , France
Centre Henri Becquerel; Oncologie Medicale, Rouen, , France
Centre Rene Huguenin; CONSULT SPECIALISEES, St Cloud, , France
Hopital Hautepierre; Hematologie Oncologie, Strasbourg, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Clinique Pasteur; Oncologie Medicale, Toulouse, , France
CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie, Berlin, , Germany
Klinikum Bremen-Mitte gGmbH; Frauenklinik, Bremen, , Germany
Klinikum Sindelfinden Boblingen, Böblingen, , Germany
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie, Darmstadt, , Germany
Klinikum Dortmund gGmbH Klinikzentrum Mitte, Dortmund, , Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde, Essen, , Germany
Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe, Frankfurt, , Germany
Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH, Fulda, , Germany
Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie, Hamburg, , Germany
HOPA MVZ GmbH, Hamburg, , Germany
Diakovere Henriettenstift, Frauenklinik, Hannover, , Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hannover, , Germany
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik, Karlsruhe, , Germany
Systemedic Frauenarzte Pruener Gang, Kiel, , Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz, Koblenz, , Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe, Koeln, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe, Lübeck, , Germany
St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz, Mainz, , Germany
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik, München, , Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe, Münster, , Germany
St. Josefs Klinik; Medizinische Klinik, Offenburg, , Germany
Praxis für Onkologie und Hämatologie, Recklinghausen, , Germany
Johanniter Klinik, Stendal, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier, , Germany
GRN Klinik Weinheim, Weinheim, , Germany
Queen Mary Hospital; Surgery, Hong Kong, , Hong Kong
Queen Elizabeth Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Tuen Mun Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Ogyi, Orszagos Gyogyszereszeti Intezet, Budapest, , Hungary
Semmelweis Egyetem Onkologiai Központ, Budapest, , Hungary
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály, Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest, , Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika, Budapest, , Hungary
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology, Budapest, , Hungary
Hospital of Aladar Petz; Dept of Oncoradiology, Gyor, , Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek, Gyula, , Hungary
Kaposi Mor County Hospital; Dept. of Oncology, Kaposvar, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly, Miskolc, , Hungary
Josa Andras Korhaz; Dept of Oncoradiology, Nyíregyháza, , Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet, Pecs, , Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged, , Hungary
Fejér Megyei Szent György Kórház; Onkológiai Osztály, Szekesfehervar, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály, Szolnok, , Hungary
Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica, Napoli, Campania, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli, Bologna, Emilia-Romagna, Italy
Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia, Cattalica, Emilia-Romagna, Italy
AUSL Cesena; Servizio di Oncologia, Cesena, Emilia-Romagna, Italy
Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica, Faenza, Emilia-Romagna, Italy
Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo, Lugo, Emilia-Romagna, Italy
Azienda USL di Ravenna; Unità Operativa di Oncologia Medica, Ravenna, Emilia-Romagna, Italy
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia, Rimini, Emilia-Romagna, Italy
Istituto Regina Elena; Oncologia Medica A, Roma, Lazio, Italy
Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna, Roma, Lazio, Italy
Asst Papa Giovanni XXIII; Oncologia Medica, Bergamo, Lombardia, Italy
ASST DI CREMONA; Dipartimento Aziendale Oncologico, Cremona, Lombardia, Italy
Ospedale Mater Salutis; Dept of Oncology, Legnago, Lombardia, Italy
ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy
IRCCS Fondazione Maugeri; Oncologia Medica II, Pavia, Lombardia, Italy
ASST LARIANA; Oncologia, S. Fermo Della Battaglia (CO), Lombardia, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica, Torino, Piemonte, Italy
Ospedale Civile; Oncologia Medica, Sassari, Sardegna, Italy
ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica, Palermo, Sicilia, Italy
Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo, Firenze, Toscana, Italy
A.O. Universitaria Pisana; Oncologia, Pisa, Toscana, Italy
Severance Hospital, Seoul, , Korea, Republic of
Seoul National University Hosp; Dept Internal Med Hem Onc, Seoul, , Korea, Republic of
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology, Seoul, , Korea, Republic of
Korea University Guro Hospital; Oncology, Seoul, , Korea, Republic of
Oaxaca Site Management Organization, Oaxaca, , Mexico
Centro Oncológico Estatal; ISSSEMYM Oncología, Toluca, , Mexico
Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte, Amsterdam, , Netherlands
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology, Arequipa, , Peru
Hospital Nacional Edgardo Rebagliati Martins, Jesus Maria, , Peru
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA, Lima, , Peru
Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica, Piura, , Peru
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny, Brzozów, , Poland
Wojewodzki Szpital Zespolony; Oddzial Chemioterapii, Elblag, , Poland
Wojewodzkie Centrum Onkologii, Gdansk, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii, Slupsk, , Poland
Spitalul Clinic Sf. Maria; Departmental De Oncologie, Bucharest, , Romania
Institute Of Oncology Bucharest; Medical Oncology, Bucharest, , Romania
Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department, Bucuresti, , Romania
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj Napoca, , Romania
Cluj Clinical County Hospital; Oncology Dept, Cluj-Napoca, , Romania
Medisprof SRL, Cluj-Napoca, , Romania
Municipal Clinical Hospital Filantropia; Oncology, Craiova, , Romania
Euroclinic Center of Oncology SRL, Iasi, , Romania
Regional Oncology Hospital of Krasnodar; Oncology, Krasnodar, , Russian Federation
Blokhin Cancer Research Center; Combined Treatment, Moscow, , Russian Federation
Semashko Central Clinical Hospital; Dept of Chemotherapy, Moscow, , Russian Federation
GUZ Perm Region Oncology Dispensary, Perm, , Russian Federation
S.-Peterburg Pavlov State Medical University ; Haematology, St Petersburg, , Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary, St Petersburg, , Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary, Stavropol, , Russian Federation
Hospital Clinica Benidorm, Benidorm, Alicante, Spain
Complejo Hospitalario Torrecardenas; Servicio de Oncologia, Almería, Almeria, Spain
Consorci Hospitalari de Terrassa, Terrassa, Barcelona, Spain
Fundacion Hospital de Alcorcon; Servicio de Oncologia, Alcorcon, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia, Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Sagunto; Servicio de Oncologia, Sagunto, Valencia, Spain
Hospital de Basurto; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital Clinic i Provincial; Servicio de Farmacia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Provincial de Castellón, Castellon, , Spain
Hospital Juan Ramon Jimenez;Servicio de Oncologia, Huelva, , Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia, Leon, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ruber Internacional;Servicio de Oncologia, Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia, Pontevedra, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Univ. Nuestra Señora de Valme;, Sevilla, , Spain
Hospital Sant Pau i Santa Tecla, Tarragona, , Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia, Toledo, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit, Bangkok, , Thailand
Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial, Chiang Mai, , Thailand
Srinagarind Hospital; Department of Surgery, Khon Kaen, , Thailand
Songklanagarind Hospital; Department of Surgery, Songkla, , Thailand
Royal Bournemouth General Hospital; Oncology, Bournemouth, , United Kingdom
Velindre Cancer Centre; Oncology Dept, Cardiff, , United Kingdom
Broomfield Hospital, Chelmsford, , United Kingdom
University Hospital of North Durham; Oncology, Durham, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Christie Hospital; Breast Cancer Research Office, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department, Peterborough, , United Kingdom
Great Western Hospital; Clinical Oncology, Swindon, , United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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