A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)
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)
2 other identifiers
interventional
452
22 countries
161
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jan 2010
Typical duration for phase_3 breast-cancer
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedStudy Start
First participant enrolled
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2015
CompletedResults Posted
Study results publicly available
October 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedAugust 14, 2018
July 1, 2018
5.3 years
November 27, 2009
August 17, 2016
July 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (Independent Assessment)
Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.
Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Secondary Outcomes (8)
Overall Survival (OS)
From randomization until death from any cause (up to 7.5 years).
Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
From randomization until death from any cause (up to 2 years)
Investigator Assessment Progression-Free Survival (PFS)
Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).
Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment
Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment
Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).
- +3 more secondary outcomes
Study Arms (2)
A: Capecitabine + Trastuzumab
ACTIVE COMPARATORB: Capecitabine + Trastuzumab + Pertuzumab
EXPERIMENTALInterventions
1000 mg/m2 po twice daily for 14 days every 3 weeks
840 mg iv loading, then 420 mg iv every 3 weeks
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Eligibility Criteria
You may qualify if:
- Adult female patients \>/=18 years of age
- Metastatic HER2 positive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Disease progression during or following trastuzumab-based therapy for 1st line metastatic breast cancer (trastuzumab must have been part of the last prior treatment regimen)
- Prior treatment with taxane-containing regimen
- Left ventricular ejection fraction (LVEF) \>/=50 percent
- For women of childbearing potential agreement to use highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by patient and/or partner. Contraception must continue for duration of study treatment and for at least 6 months after last dose of study drug treatment
You may not qualify if:
- Prior treatment with pertuzumab or capecitabine
- Concurrent treatment with other experimental drug
- Concurrent immunotherapy or anticancer hormonal therapy
- Serious concurrent disease (e.g. active infection, uncontrolled hypertension, cardiovascular disease)
- Central nervous system (CNS) metastases, which are not well controlled
- History of exposure to anthracycline cumulative dose equivalent to 360mg/m2
- History of congestive heart failure of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction within 6 months prior to randomization
- History of LVEF decline to below 50% during or after prior trastuzumab therapy or other cardiac toxicity during previous trastuzumab treatment that necessitated discontinuation of trastuzumab
- History of another cancer which could affect compliance or result interpretation
- Inadequate organ function
- Pregnant or breastfeeding women
- life expectancy \< 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (190)
Fundación Investigar
Buenos Aires, 1025, Argentina
Hospital Britanico; Oncologia
Buenos Aires, C1280AEB, Argentina
Instituto FIDES
La Plata, B1900BAJ, Argentina
Instituto de Investigaciones Clínicas Quilmes
Quilmes, 1878, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
ISIS Clinica Especializada
Santa Fe, 03000, Argentina
A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.
Krems, 3500, Austria
Landeskrankenhaus Rankweil; Interne E
Rankweil, 6830, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, 1090, Austria
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ KLINA
Brasschaat, 2930, Belgium
UZ Brussel
Brussels, 1090, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, 7100, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Saint-Joseph
Liège, 4000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
AZ Nikolaas (Lodewijk)
Sint-Niklaas, 9100, Belgium
Oncologia Sul Capixaba Servicos Medicos - Oncosul
Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, 01509-010, Brazil
Centro Oncológico de Mogi das Cruzes
São Paulo- SP, São Paulo, 08730-500, Brazil
Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
Uni Hospital For Tumours; Dept of Medical Oncology
Zagreb, 10000, Croatia
Masarykuv onkologicky ustav; Oncology II
Brno, 656 53, Czechia
University Hospital; Oncology and Radiotherapy
Hradec Králové, 500 05, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08, Czechia
Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
Prague, 180 81, Czechia
North Estonia Medical Centre Foundation; Oncology Centre
Tallinn, 13419, Estonia
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, 50406, Estonia
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, 13616, France
Centre Oncologie Du Pays Basque
Bayonne, 64100, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, 01012, France
CHU Henri Mondor; Service d'Oncologie Medicale
Créteil, 94010, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Centre Leon Berard; Oncologie Genetique
Lyon, 69373, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Hopital Saint Antoine; Sce Oncologie
Paris, 75571, France
Institut Jean Godinot; Oncologie Medicale
Reims, 51056, France
Centre Henri Becquerel; Oncologie Medicale
Rouen, 76038, France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, 92210, France
Hopital Hautepierre; Hematologie Oncologie
Strasbourg, 67098, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie
Berlin, 10117, Germany
Klinikum Sindelfinden Boblingen
Böblingen, 71032, Germany
Klinikum Bremen-Mitte gGmbH; Frauenklinik
Bremen, 28177, Germany
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, 50935, Germany
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
Darmstadt, 64283, Germany
Klinikum Dortmund gGmbH Klinikzentrum Mitte
Dortmund, 44137, Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, 45122, Germany
Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe
Frankfurt, 65929, Germany
Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH
Fulda, 36043, Germany
Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie
Hamburg, 20246, Germany
HOPA MVZ GmbH
Hamburg, 22767, Germany
Diakovere Henriettenstift, Frauenklinik
Hanover, 30559, Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625, Germany
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
Karlsruhe, 76135, Germany
Systemedic Frauenarzte Pruener Gang
Kiel, 24103, Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
Koblenz, 56068, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538, Germany
St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
Mainz, 55131, Germany
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
München, 81675, Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, 48149, Germany
St. Josefs Klinik; Medizinische Klinik
Offenburg, 77654, Germany
Praxis für Onkologie und Hämatologie
Recklinghausen, 45657, Germany
Johanniter Klinik
Stendal, 39576, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
GRN Klinik Weinheim
Weinheim, 69469, Germany
Queen Mary Hospital; Surgery
Hong Kong, 852, 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, 1051, Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, 1083, Hungary
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály
Budapest, 1106, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125, Hungary
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
Budapest, 1145, Hungary
Hospital of Aladar Petz; Dept of Oncoradiology
Győr, 9023, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5703, Hungary
Kaposi Mor County Hospital; Dept. of Oncology
Kaposvár, 7400, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, 3501, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Fejér Megyei Szent György Kórház; Onkológiai Osztály
Székesfehérvár, 8000, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
Szolnok, 5004, Hungary
Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
Napoli, Campania, 80131, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
Bologna, Emilia-Romagna, 40138, Italy
Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia
Cattalica, Emilia-Romagna, 47841, Italy
AUSL Cesena; Servizio di Oncologia
Cesena, Emilia-Romagna, 47521, Italy
Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
Faenza, Emilia-Romagna, 48018, 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, 48100, Italy
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
Rimini, Emilia-Romagna, 47900, Italy
Istituto Regina Elena; Oncologia Medica A
Rome, Lazio, 00168, Italy
Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
Rome, Lazio, 00168, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24128, Italy
ASST DI CREMONA; Dipartimento Aziendale Oncologico
Cremona, Lombardy, 26100, Italy
Ospedale Mater Salutis; Dept of Oncology
Legnago, Lombardy, 37045, Italy
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900, Italy
IRCCS Fondazione Maugeri; Oncologia Medica II
Pavia, Lombardy, 27100, Italy
ASST LARIANA; Oncologia
S. Fermo Della Battaglia (CO), Lombardy, 22020, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, 10126, Italy
Ospedale Civile; Oncologia Medica
Sassari, Sardinia, 07100, Italy
ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica
Palermo, Sicily, 90127, Italy
Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo
Florence, Tuscany, 50134, Italy
A.O. Universitaria Pisana; Oncologia
Pisa, Tuscany, 56100, Italy
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Centro Oncológico Estatal; ISSSEMYM Oncología
Toluca, 50180, Mexico
Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte
Amsterdam, 1081 HV, Netherlands
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, 04001, Peru
Hospital Nacional Edgardo Rebagliati Martins
Jesus Maria, Lima 11, Peru
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
Lima, L27, Peru
Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica
Piura, 20011, Peru
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, 36-200, Poland
Wojewodzki Szpital Zespolony; Oddzial Chemioterapii
Elblag, 82-300, Poland
Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090, Poland
Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii
Słupsk, 76200, Poland
Spitalul Clinic Sf. Maria; Departmental De Oncologie
Bucharest, 011172, Romania
Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
Bucharest, 022328, Romania
Institute Of Oncology Bucharest; Medical Oncology
Bucharest, 022338, Romania
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, 400006, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Medisprof SRL
Cluj-Napoca, 400058, Romania
Municipal Clinical Hospital Filantropia; Oncology
Craiova, Romania
Euroclinic Center of Oncology SRL
Iași, 700106, Romania
Regional Oncology Hospital of Krasnodar; Oncology
Krasnodar, 350040, Russia
Blokhin Cancer Research Center; Combined Treatment
Moscow, 115478, Russia
Semashko Central Clinical Hospital; Dept of Chemotherapy
Moscow, 129128, Russia
GUZ Perm Region Oncology Dispensary
Perm, 614 066, Russia
S.-Peterburg Pavlov State Medical University ; Haematology
Saint Petersburg, 197022, Russia
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045, Russia
Severance Hospital
Seoul, 03722, South Korea
Seoul National University Hosp; Dept Internal Med Hem Onc
Seoul, 110-744, South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736, South Korea
Korea University Guro Hospital; Oncology
Seoul, 152-703, South Korea
Hospital Clinica Benidorm
Benidorm, Alicante, 03501, Spain
Complejo Hospitalario Torrecardenas; Servicio de Oncologia
Almería, Almeria, 04009, Spain
Consorci Hospitalari de Terrassa
Terrassa, Barcelona, 08227, Spain
Hospital Provincial de Castellón
Castellon, Castellon, 12002, Spain
Fundacion Hospital de Alcorcon; Servicio de Oncologia
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Hospital de Sagunto; Servicio de Oncologia
Sagunto, Valencia, 46520, Spain
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, 48013, Spain
Hospital Clinic i Provincial; Servicio de Farmacia
Barcelona, 08036, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Juan Ramon Jimenez;Servicio de Oncologia
Huelva, 21005, Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, 24071, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Ruber Internacional;Servicio de Oncologia
Madrid, 28034, Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, 36002, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Univ. Nuestra Señora de Valme;
Seville, 41700, Spain
Hospital Sant Pau i Santa Tecla
Tarragona, 43003, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit
Bangkok, 10400, Thailand
Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, 50200, Thailand
Srinagarind Hospital; Department of Surgery
Khon Kaen, 40002, Thailand
Songklanagarind Hospital; Department of Surgery
Songkhla, 90110, Thailand
Royal Bournemouth General Hospital; Oncology
Bournemouth, BH7 7DW, United Kingdom
Velindre Cancer Centre; Oncology Dept
Cardiff, CF14 2TL, United Kingdom
Broomfield Hospital
Chelmsford, CM1 7ET, United Kingdom
University Hospital of North Durham; Oncology
Durham, DH15TW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, PE3 9GZ, United Kingdom
Great Western Hospital; Clinical Oncology
Swindon, SN3 6BB, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2009
First Posted
December 4, 2009
Study Start
January 26, 2010
Primary Completion
May 29, 2015
Study Completion
August 7, 2017
Last Updated
August 14, 2018
Results First Posted
October 13, 2016
Record last verified: 2018-07