AzTrials
AzTrials

Breast CancerPhase 3NCT01026142

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

A Phase 3 study testing Capecitabine, Pertuzumab and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 190 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Capecitabine, Pertuzumab and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
190 sitesin 23 countries
Study dates
26 Jan 2010to 7 Aug 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

190 sites in 23 countries.

190 sites in 23 countries

Spain29 sites

  • Fundacion Hospital de Alcorcon; Servicio de Oncologia

    Alcorcón, Madrid, 28922

  • Complejo Hospitalario Torrecardenas; Servicio de Oncologia

    Almería, Almeria, 04009

  • Hospital Clinic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Clinica Benidorm

    Benidorm, Alicante, 03501

  • Hospital de Basurto; Servicio de Oncologia

    Bilbao, Vizcaya, 48013

  • Hospital Provincial de Castellón

    Castellon, Castellon, 12002

  • Hospital Juan Ramon Jimenez;Servicio de Oncologia

    Huelva, 21005

  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia

    León, 24071

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ruber Internacional;Servicio de Oncologia

    Madrid, 28034

  • Fundacion Jimenez Diaz; Servicio de Oncologia

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario de Pontevedra; Servicio de Oncologia

    Pontevedra, 36002

  • Hospital de Sagunto; Servicio de Oncologia

    Sagunto, Valencia, 46520

  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

    Salamanca, 37007

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

    Santa Cruz de Tenerife, Tenerife, 38010

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Univ. Nuestra Señora de Valme;

    Seville, 41700

  • Hospital Sant Pau i Santa Tecla

    Tarragona, 43003

  • Consorci Hospitalari de Terrassa

    Terrassa, Barcelona, 08227

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

    Toledo, 45004

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany25 sites

  • CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

    Berlin, 10117

  • Klinikum Sindelfinden Boblingen

    Böblingen, 71032

  • Klinikum Bremen-Mitte gGmbH; Frauenklinik

    Bremen, 28177

  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

    Cologne, 50935

  • Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

    Darmstadt, 64283

  • Klinikum Dortmund gGmbH Klinikzentrum Mitte

    Dortmund, 44137

  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

    Essen, 45122

  • Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

    Frankfurt, 65929

  • Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

    Fulda, 36043

  • Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

    Hamburg, 20246

  • HOPA MVZ GmbH

    Hamburg, 22767

  • Diakovere Henriettenstift, Frauenklinik

    Hanover, 30559

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

    Karlsruhe, 76135

  • Systemedic Frauenarzte Pruener Gang

    Kiel, 24103

  • Institut für Versorgungsforschung in der Onkologie GbR Koblenz

    Koblenz, 56068

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

    Mainz, 55131

  • Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik

    München, 81675

  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

    Münster, 48149

  • St. Josefs Klinik; Medizinische Klinik

    Offenburg, 77654

  • Praxis für Onkologie und Hämatologie

    Recklinghausen, 45657

  • Johanniter Klinik

    Stendal, 39576

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

    Trier, 54290

  • GRN Klinik Weinheim

    Weinheim, 69469

Other trials in Germany

Italy21 sites

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24128

  • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

    Bologna, Emilia-Romagna, 40138

  • Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia

    Cattalica, Emilia-Romagna, 47841

  • AUSL Cesena; Servizio di Oncologia

    Cesena, Emilia-Romagna, 47521

  • ASST DI CREMONA; Dipartimento Aziendale Oncologico

    Cremona, Lombardy, 26100

  • Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica

    Faenza, Emilia-Romagna, 48018

  • Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

    Florence, Tuscany, 50134

  • Ospedale Mater Salutis; Dept of Oncology

    Legnago, Lombardy, 37045

  • Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

    Lugo, Emilia-Romagna

  • ASST DI MONZA; Oncologia Medica

    Monza, Lombardy, 20900

  • Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica

    Naples, Campania, 80131

  • ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica

    Palermo, Sicily, 90127

  • IRCCS Fondazione Maugeri; Oncologia Medica II

    Pavia, Lombardy, 27100

  • A.O. Universitaria Pisana; Oncologia

    Pisa, Tuscany, 56100

  • Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

    Ravenna, Emilia-Romagna, 48100

  • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

    Rimini, Emilia-Romagna, 47900

  • Istituto Regina Elena; Oncologia Medica A

    Rome, Lazio, 00168

  • Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

    Rome, Lazio, 00168

  • ASST LARIANA; Oncologia

    S. Fermo Della Battaglia (CO), Lombardy, 22020

  • Ospedale Civile; Oncologia Medica

    Sassari, Sardinia, 07100

  • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

    Turin, Piedmont, 10126

Other trials in Italy

France15 sites

  • C.H. Du Pays D'aix En Provence Service du Dr Blanc

    Aix-en-Provence, 13616

  • Centre Oncologie Du Pays Basque

    Bayonne, 64100

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • CHU Henri Mondor; Service d'Oncologie Medicale

    Créteil, 94010

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Centre Leon Berard; Oncologie Genetique

    Lyon, 69373

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Hopital Saint Antoine; Sce Oncologie

    Paris, 75571

  • Institut Jean Godinot; Oncologie Medicale

    Reims, 51056

  • Centre Henri Becquerel; Oncologie Medicale

    Rouen, 76038

  • Centre Rene Huguenin; CONSULT SPECIALISEES

    Saint-Cloud, 92210

  • Hopital Hautepierre; Hematologie Oncologie

    Strasbourg, 67098

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

Other trials in France

Hungary15 sites

  • Ogyi, Orszagos Gyogyszereszeti Intezet

    Budapest, 1051

  • Semmelweis Egyetem Onkologiai Központ

    Budapest, 1083

  • Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály

    Budapest, 1106

  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

    Budapest, 1122

  • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

    Budapest, 1125

  • Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

    Budapest, 1145

  • Hospital of Aladar Petz; Dept of Oncoradiology

    Győr, 9023

  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

    Gyula, 5703

  • Kaposi Mor County Hospital; Dept. of Oncology

    Kaposvár, 7400

  • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

    Miskolc, 3501

  • Josa Andras Korhaz; Dept of Oncoradiology

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem Áok; Onkoterapias Intezet

    Pécs, 7624

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

  • Fejér Megyei Szent György Kórház; Onkológiai Osztály

    Székesfehérvár, 8000

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

    Szolnok, 5004

Other trials in Hungary

Belgium11 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ KLINA

    Brasschaat, 2930

  • UZ Brussel

    Brussels, 1090

  • GHdC Site Notre Dame

    Charleroi, 6000

  • CH Jolimont - Lobbes (Jolimont)

    Haine-Saint-Paul, 7100

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Saint-Joseph

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • AZ Nikolaas (Lodewijk)

    Sint-Niklaas, 9100

Other trials in Belgium

United Kingdom10 sites

  • Royal Bournemouth General Hospital; Oncology

    Bournemouth, BH7 7DW

  • Velindre Cancer Centre; Oncology Dept

    Cardiff, CF14 2TL

  • Broomfield Hospital

    Chelmsford, CM1 7ET

  • University Hospital of North Durham; Oncology

    Durham, DH15TW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Peterborough City Hospital, Edith Cavell Campus; Oncology Department

    Peterborough, PE3 9GZ

  • Great Western Hospital; Clinical Oncology

    Swindon, SN3 6BB

  • Royal Cornwall Hospital; Dept of Clinical Oncology

    Truro, TR1 3LJ

Other trials in United Kingdom

Romania8 sites

  • Spitalul Clinic Sf. Maria; Departmental De Oncologie

    Bucharest, 011172

  • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

    Bucharest, 022328

  • Institute Of Oncology Bucharest; Medical Oncology

    Bucharest, 022338

  • Cluj Clinical County Hospital; Oncology Dept

    Cluj-Napoca, 400006

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Municipal Clinical Hospital Filantropia; Oncology

    Craiova

  • Euroclinic Center of Oncology SRL

    Iași, 700106

Other trials in Romania

Russia7 sites

  • Regional Oncology Hospital of Krasnodar; Oncology

    Krasnodar, 350040

  • Blokhin Cancer Research Center; Combined Treatment

    Moscow, 115478

  • Semashko Central Clinical Hospital; Dept of Chemotherapy

    Moscow, 129128

  • GUZ Perm Region Oncology Dispensary

    Perm, 614 066

  • S.-Peterburg Pavlov State Medical University ; Haematology

    Saint Petersburg, 197022

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355045

Other trials in Russia

Argentina6 sites

  • Fundación Investigar

    Buenos Aires, 1025

  • Hospital Britanico; Oncologia

    Buenos Aires, C1280AEB

  • Instituto FIDES

    La Plata, B1900BAJ

  • Instituto de Investigaciones Clínicas Quilmes

    Quilmes, 1878

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • ISIS Clinica Especializada

    Santa Fe, 03000

Other trials in Argentina

Brazil5 sites

  • Oncologia Sul Capixaba Servicos Medicos - Oncosul

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000

  • Hospital A. C. Camargo; Oncologia

    São Paulo, São Paulo, 01509-010

  • Centro Oncológico de Mogi das Cruzes

    São Paulo- SP, São Paulo, 08730-500

Other trials in Brazil

Poland5 sites

  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

    Brzozów, 36-200

  • Wojewodzki Szpital Zespolony; Oddzial Chemioterapii

    Elblag, 82-300

  • Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

  • COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

    Lublin, 20-090

  • Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii

    Słupsk, 76200

Other trials in Poland

Thailand5 sites

  • Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

    Bangkok, 10400

  • Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

    Chiang Mai, 50200

  • Srinagarind Hospital; Department of Surgery

    Khon Kaen, 40002

  • Songklanagarind Hospital; Department of Surgery

    Songkhla, 90110

Other trials in Thailand

Austria4 sites

  • A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.

    Krems, 3500

  • Landeskrankenhaus Rankweil; Interne E

    Rankweil, 6830

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

    Vienna, 1090

Other trials in Austria

Czechia4 sites

  • Masarykuv onkologicky ustav; Oncology II

    Brno, 656 53

  • University Hospital; Oncology and Radiotherapy

    Hradec Králové, 500 05

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

    Prague, 128 08

  • Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

    Prague, 180 81

Other trials in Czechia

Peru4 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

    Arequipa, 04001

  • Hospital Nacional Edgardo Rebagliati Martins

    Jesus Maria, Lima 11

  • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

    Lima, L27

  • Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

    Piura, 20011

Other trials in Peru

South Korea4 sites

  • Severance Hospital

    Seoul, 03722

  • Seoul National University Hosp; Dept Internal Med Hem Onc

    Seoul, 110-744

  • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

    Seoul, 138-736

  • Korea University Guro Hospital; Oncology

    Seoul, 152-703

Other trials in South Korea

Canada3 sites

  • Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hong Kong3 sites

  • Queen Mary Hospital; Surgery

    Hong Kong, 852

  • Queen Elizabeth Hospital; Clinical Oncology

    Hong Kong

  • Tuen Mun Hospital; Clinical Oncology

    Hong Kong

Other trials in Hong Kong

Estonia2 sites

  • North Estonia Medical Centre Foundation; Oncology Centre

    Tallinn, 13419

  • Tartu University Hospital; Clinic of Hematology and Oncology

    Tartu, 50406

Other trials in Estonia

Mexico2 sites

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Centro Oncológico Estatal; ISSSEMYM Oncología

    Toluca, 50180

Other trials in Mexico

Croatia1 site

  • Uni Hospital For Tumours; Dept of Medical Oncology

    Zagreb, 10000

Other trials in Croatia

Netherlands1 site

  • Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

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)

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.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Xeloda

    1000 mg/m2 po twice daily for 14 days every 3 weeks

  • CapecitabineDrug

    Also called Xeloda

    1250 mg/m2 po twice daily for 14 days every 3 weeks

  • PertuzumabDrug

    Also called Perjeta

    840 mg iv loading, then 420 mg iv every 3 weeks

  • TrastuzumabDrug

    Also called Herceptin

    8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks

Study groups in NCT01026142
Study groupRoleWhat they receive
A: Capecitabine + TrastuzumabActive comparatorNot described
Receives: Drug: Capecitabine; Drug: Trastuzumab
B: Capecitabine + Trastuzumab + PertuzumabExperimentalNot described
Receives: Drug: Capecitabine; Drug: Pertuzumab; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Survival (OS)

    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.

    Measured: From randomization until death from any cause (up to 7.5 years).

  2. Overall Survival (OS) Rate Based on a 2-year Truncated Analysis

    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.

    Measured: From randomization until death from any cause (up to 2 years)

  3. Investigator Assessment Progression-Free Survival (PFS)

    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.

    Measured: 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).

  4. Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment

    Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment.

    Measured: 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).

  5. Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment

    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.

    Measured: 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).

  6. Overall Objective Response Rate (ORR)

    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.

    Measured: 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).

  7. Clinical Benefit Rate (CBR)

    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.

    Measured: 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).

  8. Duration of Objective Response

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2009 (estimated)
  2. Study start26 Jan 2010
  3. Primary completion29 May 2015
  4. Study completion7 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026142
Sponsor's protocol ID
MO22324
Other IDs
2008-006801-17, 2008
Status last verified
Jul 2018
First submitted
27 Nov 2009
Last updated
14 Aug 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Pertuzumab and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 190 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in Spain, Germany, Italy, France, Hungary and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in