A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

July 16, 2018 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

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

  • Argentina
      • Buenos Aires, Argentina, 1025
        • Fundación Investigar
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico; Oncologia
      • La Plata, Argentina, B1900BAJ
        • Instituto FIDES
      • Quilmes, Argentina, 1878
        • Instituto De Investigaciones Clinicas Quilmes
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
      • Santa Fe, Argentina, 03000
        • ISIS Clinica Especializada
  • Austria
      • Krems, Austria, 3500
        • A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.
      • Rankweil, Austria, 6830
        • Landeskrankenhaus Rankweil; Interne E
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Charleroi, Belgium, 6000
        • GHdC Site Notre Dame
      • Haine-Saint-Paul, Belgium, 7100
        • CH Jolimont - Lobbes (Jolimont)
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Liège, Belgium, 4000
        • Clinique Saint-Joseph
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas (Lodewijk)
  • Brazil
    • ES
      • Cachoeiro Do Itapemirim, ES, Brazil, 29308-014
        • Oncologia Sul Capixaba Servicos Medicos - Oncosul
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
    • SP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
      • Sao Paulo, SP, Brazil, 01509-010
        • Hospital A. C. Camargo; Oncologia
      • São Paulo- SP, SP, Brazil, 08730-500
        • Centro Oncológico de Mogi das Cruzes
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Durham Regional Cancer Centre
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Croatia
      • Zagreb, Croatia, 10000
        • Uni Hospital For Tumours; Dept of Medical Oncology
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav; Oncology II
      • Hradec Kralove, Czechia, 500 05
        • University Hospital; Oncology and Radiotherapy
      • Praha, Czechia, 180 81
        • Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
      • Praha 2, Czechia, 128 08
        • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation; Oncology Centre
      • Tartu, Estonia, 50406
        • Tartu University Hospital; Clinic of Hematology and Oncology
  • France
      • Aix En Provence, France, 13616
        • C.H. Du Pays D'aix En Provence Service du Dr Blanc
      • Bayonne, France, 64100
        • Centre Oncologie Du Pays Basque
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Creteil, France, 94010
        • CHU Henri Mondor; Service d'Oncologie Medicale
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Lyon, France, 69373
        • Centre Leon Berard; Oncologie Genetique
      • Nice, France, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75571
        • Hopital Saint Antoine; Sce Oncologie
      • Reims CEDEX, France, 51056
        • Institut Jean Godinot; Oncologie Medicale
      • Rouen, France, 76038
        • Centre Henri Becquerel; Oncologie Medicale
      • St Cloud, France, 92210
        • Centre Rene Huguenin; CONSULT SPECIALISEES
      • Strasbourg, France, 67098
        • Hopital Hautepierre; Hematologie Oncologie
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • Toulouse, France, 31076
        • Clinique Pasteur; Oncologie Medicale
  • Germany
      • Berlin, Germany, 10117
        • CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie
      • Bremen, Germany, 28177
        • Klinikum Bremen-Mitte gGmbH; Frauenklinik
      • Böblingen, Germany, 71032
        • Klinikum Sindelfinden Boblingen
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
      • Dortmund, Germany, 44137
        • Klinikum Dortmund gGmbH Klinikzentrum Mitte
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
      • Frankfurt, Germany, 65929
        • Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe
      • Fulda, Germany, 36043
        • Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH
      • Hamburg, Germany, 22767
        • HOPA MVZ GmbH
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
      • Hannover, Germany, 30559
        • Diakovere Henriettenstift, Frauenklinik
      • Karlsruhe, Germany, 76135
        • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik
      • Kiel, Germany, 24103
        • Systemedic Frauenarzte Pruener Gang
      • Koblenz, Germany, 56068
        • Institut für Versorgungsforschung in der Onkologie GbR Koblenz
      • Koeln, Germany, 50935
        • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
      • Mainz, Germany, 55131
        • St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
      • Münster, Germany, 48149
        • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
      • Offenburg, Germany, 77654
        • St. Josefs Klinik; Medizinische Klinik
      • Recklinghausen, Germany, 45657
        • Praxis für Onkologie und Hämatologie
      • Stendal, Germany, 39576
        • Johanniter Klinik
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
      • Weinheim, Germany, 69469
        • GRN Klinik Weinheim
  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital; Clinical Oncology
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital; Surgery
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital; Clinical Oncology
  • Hungary
      • Budapest, Hungary, 1051
        • Ogyi, Orszagos Gyogyszereszeti Intezet
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
      • Budapest, Hungary, 1145
        • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Onkologiai Központ
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
      • Budapest, Hungary, 1106
        • Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály
      • Gyor, Hungary, 9023
        • Hospital of Aladar Petz; Dept of Oncoradiology
      • Gyula, Hungary, 5703
        • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
      • Kaposvar, Hungary, 7400
        • Kaposi Mor County Hospital; Dept. of Oncology
      • Miskolc, Hungary, 3501
        • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Pecs, Hungary, 7624
        • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
      • Szekesfehervar, Hungary, 8000
        • Fejér Megyei Szent György Kórház; Onkológiai Osztály
      • Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
      • Cattalica, Emilia-Romagna, Italy, 47841
        • Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia
      • Cesena, Emilia-Romagna, Italy, 47521
        • AUSL Cesena; Servizio di Oncologia
      • Faenza, Emilia-Romagna, Italy, 48018
        • Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
      • Lugo, Emilia-Romagna, Italy
        • Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
      • Rimini, Emilia-Romagna, Italy, 47900
        • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Istituto Regina Elena; Oncologia Medica A
      • Roma, Lazio, Italy, 00168
        • Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
    • Lombardia
      • Bergamo, Lombardia, Italy, 24128
        • Asst Papa Giovanni XXIII; Oncologia Medica
      • Cremona, Lombardia, Italy, 26100
        • ASST DI CREMONA; Dipartimento Aziendale Oncologico
      • Legnago, Lombardia, Italy, 37045
        • Ospedale Mater Salutis; Dept of Oncology
      • Monza, Lombardia, Italy, 20900
        • ASST DI MONZA; Oncologia Medica
      • Pavia, Lombardia, Italy, 27100
        • IRCCS Fondazione Maugeri; Oncologia Medica II
      • S. Fermo Della Battaglia (CO), Lombardia, Italy, 22020
        • ASST LARIANA; Oncologia
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • Ospedale Civile; Oncologia Medica
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo
      • Pisa, Toscana, Italy, 56100
        • A.O. Universitaria Pisana; Oncologia
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hosp; Dept Internal Med Hem Onc
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital; Oncology
  • Mexico
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
      • Toluca, Mexico, 50180
        • Centro Oncológico Estatal; ISSSEMYM Oncología
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte
  • Peru
      • Arequipa, Peru, 04001
        • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
      • Jesus Maria, Peru, Lima 11
        • Hospital Nacional Edgardo Rebagliati Martins
      • Lima, Peru, L27
        • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
      • Piura, Peru, 20011
        • Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
      • Elblag, Poland, 82-300
        • Wojewodzki Szpital Zespolony; Oddzial Chemioterapii
      • Gdansk, Poland, 80-219
        • Wojewodzkie Centrum Onkologii
      • Lublin, Poland, 20-090
        • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
      • Slupsk, Poland, 76200
        • Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii
  • Romania
      • Bucharest, Romania, 022338
        • Institute Of Oncology Bucharest; Medical Oncology
      • Bucharest, Romania, 011172
        • Spitalul Clinic Sf. Maria; Departmental De Oncologie
      • Bucuresti, Romania, 022328
        • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Cluj-Napoca, Romania, 400006
        • Cluj Clinical County Hospital; Oncology Dept
      • Cluj-Napoca, Romania, 400058
        • Medisprof SRL
      • Craiova, Romania
        • Municipal Clinical Hospital Filantropia; Oncology
      • Iasi, Romania, 700106
        • Euroclinic Center of Oncology SRL
  • Russian Federation
      • Krasnodar, Russian Federation, 350040
        • Regional Oncology Hospital of Krasnodar; Oncology
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center; Combined Treatment
      • Moscow, Russian Federation, 129128
        • Semashko Central Clinical Hospital; Dept of Chemotherapy
      • Perm, Russian Federation, 614 066
        • GUZ Perm Region Oncology Dispensary
      • St Petersburg, Russian Federation, 197022
        • Saint-Petersburg City Clinical Oncology Dispensary
      • St Petersburg, Russian Federation, 197022
        • S.-Peterburg Pavlov State Medical University ; Haematology
      • Stavropol, Russian Federation, 355045
        • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospital Duran i Reynals
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Farmacia
      • Castellon, Spain, 12002
        • Hospital Provincial de Castellon
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez;Servicio de Oncologia
      • Leon, Spain, 24071
        • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz; Servicio de Oncologia
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional;Servicio de Oncologia
      • Pontevedra, Spain, 36002
        • Complejo Hospitalario de Pontevedra; Servicio de Oncologia
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41700
        • Hospital Univ. Nuestra Señora de Valme;
      • Tarragona, Spain, 43003
        • Hospital Sant Pau i Santa Tecla
      • 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, 46026
        • Hospital Universitario la Fe; Servicio de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Benidorm, Alicante, Spain, 03501
        • Hospital Clinica Benidorm
    • Almeria
      • Almería, Almeria, Spain, 04009
        • Complejo Hospitalario Torrecardenas; Servicio de Oncologia
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Hospitalari de Terrassa
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon; Servicio de Oncologia
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias;servicio de Oncologia
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital de Sagunto; Servicio de Oncologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto; Servicio de Oncologia
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital; Department of Surgery
      • Songkla, Thailand, 90110
        • Songklanagarind Hospital; Department of Surgery
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital; Oncology
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre; Oncology Dept
      • Chelmsford, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Durham, United Kingdom, DH15TW
        • University Hospital of North Durham; Oncology
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Manchester, United Kingdom, M20 4QL
        • Christie Hospital; Breast Cancer Research Office
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital, Edith Cavell Campus; Oncology Department
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital; Clinical Oncology
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital; Dept of Clinical Oncology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Capecitabine + Trastuzumab
Drug: Capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks
Other Names:
  • Xeloda
Drug: Capecitabine
1250 mg/m2 po twice daily for 14 days every 3 weeks
Other Names:
  • Xeloda
Drug: Trastuzumab
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Other Names:
  • Herceptin
Experimental: B: Capecitabine + Trastuzumab + Pertuzumab
Drug: Capecitabine
1000 mg/m2 po twice daily for 14 days every 3 weeks
Other Names:
  • Xeloda
Drug: Capecitabine
1250 mg/m2 po twice daily for 14 days every 3 weeks
Other Names:
  • Xeloda
Drug: Trastuzumab
8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks
Other Names:
  • Herceptin
Drug: Pertuzumab
840 mg iv loading, then 420 mg iv every 3 weeks
Other Names:
  • Perjeta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (Independent Assessment)
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death from any cause (up to 7.5 years).
Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status.
From randomization until death from any cause (up to 7.5 years).
Overall Survival (OS) Rate Based on a 2-year Truncated Analysis
Time Frame: From randomization until death from any cause (up to 2 years)
The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.
From randomization until death from any cause (up to 2 years)
Investigator Assessment Progression-Free Survival (PFS)
Time Frame: 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).
Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is 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.
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
Time Frame: 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 Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on 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
Time Frame: 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) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.
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).
Overall Objective Response Rate (ORR)
Time Frame: 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).
Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
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).
Clinical Benefit Rate (CBR)
Time Frame: 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).
Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.
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).
Duration of Objective Response
Time Frame: 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).
Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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)

January 26, 2010

Primary Completion (Actual)

May 29, 2015

Study Completion (Actual)

August 7, 2017

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO22324
  • 2008-006801-17 (EudraCT Number)

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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