Clinical trial NCT01026142: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 452
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression Free Survival (Independent Assessment)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: From randomization until death from any cause (up to 7.5 years).
measure: Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
timeFrame: From randomization until death from any cause (up to 2 years)
measure: Investigator Assessment Progression-Free Survival (PFS)
timeFrame: 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).
measure: Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment
timeFrame: 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).
measure: Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment
timeFrame: 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).
measure: Overall Objective Response Rate (ORR)
timeFrame: 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).
measure: Clinical Benefit Rate (CBR)
timeFrame: 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).
measure: Duration of Objective Response
timeFrame: 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).
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundación Investigar
city: Buenos Aires
country: Argentina
facility: Hospital Britanico; Oncologia
city: La Plata
country: Argentina
facility: Instituto FIDES
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clínicas Quilmes
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Krems
country: Austria
facility: A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.
city: Rankweil
country: Austria
facility: Landeskrankenhaus Rankweil; Interne E
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brussel
country: Belgium
facility: UZ Brussel
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Haine-Saint-Paul
country: Belgium
facility: CH Jolimont - Lobbes (Jolimont)
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Liège
country: Belgium
facility: Clinique Saint-Joseph
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas (Lodewijk)
city: Cachoeiro Do Itapemirim
country: Brazil
facility: Oncologia Sul Capixaba Servicos Medicos - Oncosul
state: ES
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo; Oncologia
state: SP
city: São Paulo- SP
country: Brazil
facility: Centro Oncológico de Mogi das Cruzes
state: SP
city: Oshawa
country: Canada
facility: Durham Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Zagreb
country: Croatia
facility: Uni Hospital For Tumours; Dept of Medical Oncology
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav; Oncology II
city: Hradec Kralove
country: Czechia
facility: University Hospital; Oncology and Radiotherapy
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Praha
country: Czechia
facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Centre
city: Tartu
country: Estonia
facility: Tartu University Hospital; Clinic of Hematology and Oncology
city: Aix En Provence
country: France
facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc
city: Bayonne
country: France
facility: Centre Oncologie Du Pays Basque
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Creteil
country: France
facility: CHU Henri Mondor; Service d'Oncologie Medicale
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Lyon
country: France
facility: Centre Leon Berard; Oncologie Genetique
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Antoine; Sce Oncologie
city: Reims CEDEX
country: France
facility: Institut Jean Godinot; Oncologie Medicale
city: Rouen
country: France
facility: Centre Henri Becquerel; Oncologie Medicale
city: St Cloud
country: France
facility: Centre Rene Huguenin; CONSULT SPECIALISEES
city: Strasbourg
country: France
facility: Hopital Hautepierre; Hematologie Oncologie
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Berlin
country: Germany
facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH; Frauenklinik
city: Böblingen
country: Germany
facility: Klinikum Sindelfinden Boblingen
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe
city: Fulda
country: Germany
facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie
city: Hamburg
country: Germany
facility: HOPA MVZ GmbH
city: Hannover
country: Germany
facility: Diakovere Henriettenstift, Frauenklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
city: Karlsruhe
country: Germany
facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
city: Kiel
country: Germany
facility: Systemedic Frauenarzte Pruener Gang
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
city: Mainz
country: Germany
facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
city: Offenburg
country: Germany
facility: St. Josefs Klinik; Medizinische Klinik
city: Recklinghausen
country: Germany
facility: Praxis für Onkologie und Hämatologie
city: Stendal
country: Germany
facility: Johanniter Klinik
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
city: Weinheim
country: Germany
facility: GRN Klinik Weinheim
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Surgery
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital; Clinical Oncology
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital; Clinical Oncology
city: Budapest
country: Hungary
facility: Ogyi, Orszagos Gyogyszereszeti Intezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Onkologiai Központ
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
city: Gyor
country: Hungary
facility: Hospital of Aladar Petz; Dept of Oncoradiology
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
city: Kaposvar
country: Hungary
facility: Kaposi Mor County Hospital; Dept. of Oncology
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
city: Nyíregyháza
country: Hungary
facility: Josa Andras Korhaz; Dept of Oncoradiology
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Kórház; Onkológiai Osztály
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
city: Napoli
country: Italy
facility: Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
state: Campania
city: Bologna
country: Italy
facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
state: Emilia-Romagna
city: Cattalica
country: Italy
facility: Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia
state: Emilia-Romagna
city: Cesena
country: Italy
facility: AUSL Cesena; Servizio di Oncologia
state: Emilia-Romagna
city: Faenza
country: Italy
facility: Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
state: Emilia-Romagna
city: Lugo
country: Italy
facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Istituto Regina Elena; Oncologia Medica A
state: Lazio
city: Roma
country: Italy
facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Cremona
country: Italy
facility: ASST DI CREMONA; Dipartimento Aziendale Oncologico
state: Lombardia
city: Legnago
country: Italy
facility: Ospedale Mater Salutis; Dept of Oncology
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: Pavia
country: Italy
facility: IRCCS Fondazione Maugeri; Oncologia Medica II
state: Lombardia
city: S. Fermo Della Battaglia (CO)
country: Italy
facility: ASST LARIANA; Oncologia
state: Lombardia
city: Torino
country: Italy
facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
state: Piemonte
city: Sassari
country: Italy
facility: Ospedale Civile; Oncologia Medica
state: Sardegna
city: Palermo
country: Italy
facility: ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica
state: Sicilia
city: Firenze
country: Italy
facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana; Oncologia
state: Toscana
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hosp; Dept Internal Med Hem Onc
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital; Oncology
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Toluca
country: Mexico
facility: Centro Oncológico Estatal; ISSSEMYM Oncología
city: Amsterdam
country: Netherlands
facility: Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
city: Jesus Maria
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
city: Piura
country: Peru
facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony; Oddzial Chemioterapii
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii
city: Lublin
country: Poland
facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
city: Slupsk
country: Poland
facility: Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii
city: Bucharest
country: Romania
facility: Spitalul Clinic Sf. Maria; Departmental De Oncologie
city: Bucharest
country: Romania
facility: Institute Of Oncology Bucharest; Medical Oncology
city: Bucuresti
country: Romania
facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Cluj Clinical County Hospital; Oncology Dept
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Craiova
country: Romania
facility: Municipal Clinical Hospital Filantropia; Oncology
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Krasnodar
country: Russian Federation
facility: Regional Oncology Hospital of Krasnodar; Oncology
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
city: Moscow
country: Russian Federation
facility: Semashko Central Clinical Hospital; Dept of Chemotherapy
city: Perm
country: Russian Federation
facility: GUZ Perm Region Oncology Dispensary
city: St Petersburg
country: Russian Federation
facility: S.-Peterburg Pavlov State Medical University ; Haematology
city: St Petersburg
country: Russian Federation
facility: Saint-Petersburg City Clinical Oncology Dispensary
city: Stavropol
country: Russian Federation
facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
city: Benidorm
country: Spain
facility: Hospital Clinica Benidorm
state: Alicante
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia
state: Almeria
city: Terrassa
country: Spain
facility: Consorci Hospitalari de Terrassa
state: Barcelona
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
state: Tenerife
city: Sagunto
country: Spain
facility: Hospital de Sagunto; Servicio de Oncologia
state: Valencia
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de Farmacia
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospital Duran i Reynals
city: Castellon
country: Spain
facility: Hospital Provincial de Castellón
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ruber Internacional;Servicio de Oncologia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital La Paz
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Univ. Nuestra Señora de Valme;
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital; Department of Surgery
city: Songkla
country: Thailand
facility: Songklanagarind Hospital; Department of Surgery
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital; Oncology
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre; Oncology Dept
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Durham
country: United Kingdom
facility: University Hospital of North Durham; Oncology
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department
city: Swindon
country: United Kingdom
facility: Great Western Hospital; Clinical Oncology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital; Dept of Clinical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: