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A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01572038
Recruitment Status : Active, not recruiting
First Posted : April 5, 2012
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Docetaxel Drug: Nab-paclitaxel Drug: Paclitaxel Drug: Pertuzumab Drug: Trastuzumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1436 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Actual Study Start Date : June 1, 2012
Estimated Primary Completion Date : September 28, 2019
Estimated Study Completion Date : September 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pertuzumab + Trastuzumab + Taxane
Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.
Drug: Docetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Nab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Paclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Pertuzumab
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
Other Name: RO 43-68451

Drug: Trastuzumab
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
Other Name: Herceptin




Primary Outcome Measures :
  1. Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation [ Time Frame: Baseline up to approximately 7 years 3 months ]
  2. Percentage of Participants who Died, Reported by Cause of Death [ Time Frame: Baseline up to approximately 7 years 3 months ]
  3. Percentage of Participants with Congestive Heart Failure (CHF) [ Time Frame: Baseline up to approximately 7 years 3 months ]
  4. Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to approximately 7 years 3 months ]
  5. Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) prior to study drug administration during treatment period, 1 month post-treatment safety follow-up (approximately 7 years 3 months overall) ]
  6. Time to Onset of the First Episode of CHF [ Time Frame: Baseline up to approximately 7 years 3 months ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
  2. Overall Survival [ Time Frame: Screening up to death due to any cause (up to approximately 7 years 3 months) ]
  3. Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
  4. Percentage of Response with Clinical Benefit Response (CR, PR or Stable Disease [SD; for At Least 6 months] Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v.1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
  5. Duration of Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
  6. Time to Response Among Participants with Best Response of PR or CR as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
  7. Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores for Female Participants Only [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) during treatment period, 1 and 3 months post-treatment safety follow-up (approximately 7 years 3 months overall) ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
  • HER2-positive breast cancer
  • Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • LVEF of at least 50 percent (%)

Exclusion Criteria:

  • Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
  • Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
  • Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
  • History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
  • Central nervous system (CNS) metastases
  • Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
  • History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Inadequate bone marrow, liver or renal function
  • Uncontrolled hypertension
  • Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572038


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Locations
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Algeria
CPMC; Service d'Oncologie Médicale
Algiers, Algeria, 16000
Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Australia, Australian Capital Territory
Canberra Hospital; Medical Oncology
Canberra, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Royal Prince Alfred Hospital; Medical Oncology
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
HOCA Chermside
Chermside, Queensland, Australia, 4032
Mater Hospital; Cancer Services
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Austin and Repatriation Medical Centre; Cancer Services
Melbourne, Victoria, Australia, 3084
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia, 3052
Austria
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
Graz, Austria, 8036
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz, Austria, 8036
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, Austria, 6020
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
Linz, Austria, 4010
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
Steyr, Austria, 4400
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
Wien, Austria, 1090
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Wien, Austria, 1090
Belgium
UZ Brussel
Brussel, Belgium, 1090
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
CHU Sart-Tilman
Liège, Belgium, 4000
Brazil
Oncologistas Associados
Rio de Janeiro, RJ, Brazil, 22271-110
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-080
Hospital das Clinicas - FMUSP Ribeirao Preto
Ribeirao Preto, SP, Brazil, 14048-900
Hospital Sirio Libanes; Centro de Oncologia
Sao Paulo, SP, Brazil, 01308-050
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Hospital Sao Jose
São Paulo, SP, Brazil, CEP 01321-001
Canada, Alberta
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Lion'S Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Bcca - Vancouver Island Cancer Centre; Oncology
Victoria, British Columbia, Canada, V8R 6V5
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
William Osler Health System Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CSSS champlain - Charles-Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C2
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
China
Beijing Cancer Hospital
Beijing, China, 100142
Southwest Hospital , Third Military Medical University
Chongqing, China, 400038
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Heilongjiang Provincial Tumor Hospital
Harbin, China, 150040
Jiangsu Cancer Hospital
Nanjing, China, 210009
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Tianjin Cancer Hospital
Tianjin, China, 300060
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, China, 710032
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China, 710061
Ecuador
Hospital Solca Portoviejo; Oncologia
Portoviejo, Ecuador, EC130104
Hospital Solca Quito; Oncologia
Quito, Ecuador, EC170124
Egypt
Manial Specialized Hospital; Oncology
Cairo, Egypt, 11555
El Mokatam HIO Hospital
Cairo, Egypt, 11654
Nci; Oncology Dept
Cairo, Egypt, 11796
Estonia
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, Estonia, 13419
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, Estonia, 50406
Finland
Helsinki University Central Hospital; Oncology Clinics
Helsinki, Finland, 00029
Satakunta Central Hospital; Oncology
Pori, Finland, 28500
Tampere University Hospital; Dept of Oncology
Tampere, Finland, 33520
Turku Uni Central Hospital; Oncology Clinics
Turku, Finland, 20520
France
Clinique Du Docteur Calabet; Cromg
Agen, France, 47000
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France, 80090
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, France, 33077
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg En Bresse, France, 01012
Chi De Creteil; Radiotherapie Oncologie
Creteil, France, 94010
Centre Leonard De Vinci;Chimiotherapie
Dechy, France, 59187
Fondation Clement Drevon; Oncology
Dijon, France, 21000
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France, 21079
Clinique Sainte Marguerite; Oncologie Medicale
Hyeres, France, 83400
Polyclinique de Blois; Chimiotherapie Ambulatoire
La Chaussee St Victor, France, 41260
Clinique Victor Hugo
LeMans, France, 72000
Centre Hartmann
Levallois Perret, France, 92300
Polyclinique Du Bois; Centre Bourgogne
Lille, France, 59000
Clinique Chenieux; Oncology
Limoges, France, 87039
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Institut Paoli Calmettes; Oncologie Medicale
Marseille, France, 13273
Centre Azureen De Cancerologie; Cons externes
Mougins, France, 06250
Polyclinique Du Languedoc; Chimiotherapie
Narbonne, France, 11780
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, France, 75014
Hopital Hotel Dieu; Oncologie Medicale
Paris, France, 75181
Hia Du Val De Grace; Radiotherapie Oncologie
Paris, France, 75230
Institut Curie; Oncologie Medicale
Paris, France, 75231
Hopital Saint Louis; Service Onco Thoracique
Paris, France, 75475
Hopital Des Diaconesses; Oncologie
Paris, France, 75571
Centre Catalan D' Oncologie
Perpignan, France, 66000
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, France, 51057
Centre Eugene Marquis; Unite Huguenin
Rennes, France, 35042
Centre Rene Huguenin; ONCOLOGIE GENETIQUE
Saint Cloud, France, 92210
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint Gregoire, France, 35768
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
Institut D Oncologie Medical
Strasbourg, France, 67000
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Hopital Prive Drome Ardeche; Hopital De Jour
Valence, France, 26000
Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie
Valenciennes, France, 59326
Germany
Klinikum am Bruderwald; Frauenklinik
Bamberg, Germany, 96049
Gynaekologicum Bremen; Prof. Dr. Willibald Schröder
Bremen, Germany, 28211
Klinikum Bremerhaven Reinkenheide; Frauenklinik
Bremerhaven, Germany, 27574
Universitätsklinikum Erlangen; Frauenklinik
Erlangen, Germany, 91054
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, Germany, 45122
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
Esslingen, Germany, 73730
AGAPLESION Markus-Krankenhaus
Frankfurt, Germany, 60431
SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe
Gera, Germany, 07548
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, Germany, 20246
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hannover, Germany, 30177
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
Homburg/Saar, Germany, 66424
St.-Vincenz-Krankenhaus; Frauenklinik
Limburg, Germany, 65549
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, Germany, 23538
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Mönchengladbach, Germany, 41061
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
München, Germany, 81675
Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe
Neuruppin, Germany, 16816
Med. Versorgungszentrum GbR - Praxis Pihusch
Rosenheim, Germany, 83022
Agaplesion Diakonieklinikum Rotenburg
Rotenburg/Wümme, Germany, 27356
Praxis Dr. Wagner
Saarbruecken, Germany, 66113
Onkologische Schwerpunktpraxis
Soest, Germany, 59494
Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe
Torgau, Germany, 04860
Universitätsklinik Tübingen; Frauenklinik
Tübingen, Germany, 72076
Greece
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, Greece, 115 22
Hippokratio Hospital; 2Nd Internal Medicine
Athens, Greece, 11527
University General Hospital of Heraklion
Crete, Greece, 71110
University Hospital of Larissa; Oncology
Larissa, Greece, 41 110
University Hospital of Patras Medical Oncology
Patras, Greece, 265 04
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, Greece, 185 47
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, Greece, 546 29
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, Greece, 546 45
Hong Kong
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong, Hong Kong
Hungary
Szent Margit Hospital; Dept. of Oncology
Budapest, Hungary, 1032
Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
Budapest, Hungary, 1097
Orszagos Onkologial Intezet; Onkologiai Osztaly X
Budapest, Hungary, 1122
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, Hungary, 4032
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, Hungary, 3501
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, Hungary, 6720
Israel
Soroka Medical Center; Oncology Dept
Beer Sheva, Israel, 8410101
Rambam Medical Center; Oncology
Haifa, Israel, 3525408
Wolfson Hospital; Oncology
Holon, Israel, 58100
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, Israel, 91031
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112001
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Nahariya Hospital; Oncology
Nahariya, Israel, 22100
Rabin Medical Center; Oncology Dept
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Kaplan Medical Center; Oncology Inst.
Rehovot, Israel, 7610001
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv, Israel, 6423906
Assuta Medical Centre; Oncology
Tel Aviv, Israel
Assaf Harofeh; Oncology
Zerifin, Israel, 6093000
Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, Italy, 83100
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
Piacenza, Emilia-Romagna, Italy, 29100
Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
Ravenna, Emilia-Romagna, Italy, 48100
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli-Venezia Giulia, Italy, 33100
Ospedale Belcolle Di Viterbo; Oncologia
Viterbo, Lazio, Italy, 01100
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
Genova, Liguria, Italy, 16128
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardia, Italy, 24128
Ospedale Mater Salutis; Dept of Oncology
Legnago, Lombardia, Italy, 37045
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
Mantova, Lombardia, Italy, 46100
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.
Pavia, Lombardia, Italy, 27100
Ospedali Riuniti Di Ancona; Oncology
Ancona, Marche, Italy, 60121
Ospedale Di Macerata; Oncologia
Macerata, Marche, Italy, 62100
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piemonte, Italy, 28100
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
Ponderano (BI), Piemonte, Italy, 13875
Fondazione Del Piemonte; Medical Oncology
Torino, Piemonte, Italy, 70060
Ospedale Civile SS Annunziata; oncologia medica
Sassari, Sardegna, Italy, 07100
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicilia, Italy, 98030
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Firenze, Toscana, Italy, 50139
Arcispedale S.Anna; Oncologia Medica
Cona (Ferrara), Veneto, Italy, 44124
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon, 1107 2020
Hotel Dieu de France; Oncology
Beirut, Lebanon, 2063 1111
Lithuania
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Uni Oncology Inst. ; Chemo - Radiation Dept
Vilnius, Lithuania, 08660
Mexico
Centro Estatal de Oncología de Campeche
Campeche, Mexico, 24096
Iem-Fucam
D.f., Mexico, 04980
Medica Sur Centro Oncologico Integral
D.f., Mexico, 14050
Instituto Nacional de Cancerologia; Oncology
Distrito Federal, Mexico, 14080
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, Mexico, 03100
Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia
Mexico City, Mexico, 06720
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Mexico City, Mexico, Tlalpan 14000
Hospital General de México; Unidad de Oncologia
Mexico DF, Mexico, 06726
Cancerologia de Queretaro; Oncologia
Queretaro, Queretaro, Mexico, 76090
Morocco
Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Rabat, Morocco, 10000
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
Apeldoorn, Netherlands, 7334 DZ
Rijnstate Ziekenhuis; Inwendige Geneeskunde
Arnhem, Netherlands, 6815 AD
Wilhelmina Ziekenhuis; Inwendige Geneeskunde
Assen, Netherlands, 9401 RK
Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
Dordrecht, Netherlands, 3318 AT
Catharina ZKHS; Inwendige Geneeskunde Afd.
Eindhoven, Netherlands, 5623 EJ
Martini Ziekenhuis; Dept of Internal Medicine
Groningen, Netherlands, 9728 NT
Diaconessenhuis Leiden
Leiden, Netherlands, 2334 CK
Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
Leidschendam, Netherlands, 2262 BA
Ikazia Ziekenhuis; Interne Oncologie
Rotterdam, Netherlands, 3083 AN
Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
Tilburg, Netherlands, 5042 AD
Vie Curie
Venlo, Netherlands, 5912 BL
Pakistan
Shifa International Hospital; Department of Oncology
Islamabad, Pakistan, 44000
Shaukat Khanum Memorial Cancer Hospital; Department of Oncology
Lahore, Pakistan, 54000
Hameed Latif Hospital; Department of Oncology
Lahore, Pakistan, 54600
Peru
Instituto;Oncologico Miraflores
Lima, Peru, 18
Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología
Lima, Peru, Lima11
Poland
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, Poland, 15-027
Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
Kielce, Poland, 25-734
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, Poland, 31-531
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
Lodz, Poland, 93-513
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, Poland, 05-400
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
Warszawa, Poland, 02-781
Portugal
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, Portugal, 3000-075
Hospital do Espirito Santo; Servico de Oncologia Medica
Evora, Portugal, 7000-811
Centro Clinico Champalimaud; Oncologia Medica
Lisboa, Portugal, 1400-038
Hospital da Luz; Departamento de Oncologia Medica
Lisboa, Portugal, 1500-650
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa, Portugal, 1649-035
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, Portugal, 2674-514
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Oncologia
Porto, Portugal, 4200-319
Saudi Arabia
King Faisal Specialist Hospital & Research Centre; Oncology
Riyadh, Saudi Arabia, 11211
King Abdul Aziz Medical City, King Fahd National Guard; Oncology
Riyadh, Saudi Arabia, 22490
Serbia
Institute for Onc/Rad Serbia
Belgrade, Serbia, 11000
Oncology Institute of Vojvodina
Sremska Kamenica, Serbia, 21204
Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Spain
Hospital Virgen de los Lirios; Servicio de Oncologia
Alcoy, Alicante, Spain, 03804
Hospital General de Elda; Servicio de Oncologia
Elda, Alicante, Spain, 03600
Hospital de Cabueñes; Servicio de Oncologia
Gijon, Asturias, Spain, 33394
Complejo Hospitalario de Althaia; Servicio de Oncologia
Manresa, Barcelona, Spain, 08243
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital de Jerez de la Frontera; Servicio de Oncologia
Jerez de La Frontera, Cadiz, Spain, 11407
Hospital de Barbastro; Servicio de Oncologia
Barbastro, Huesca, Spain, 22300
Hospital Universitario Son Espases
Palma De Mallorca, Islas Baleares, Spain, 07014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain, 15706
Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia
Logroño, LA Rioja, Spain, 26006
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35020
Fundacion Hospital de Alcorcon; Servicio de Oncologia
Alcorcon, Madrid, Spain, 28922
Hospital Severo Ochoa; Servicio de Oncologia
Leganes, Madrid, Spain, 28911
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, Spain, 43204
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital de Sagunto; Servicio de Oncologia
Sagunto, Valencia, Spain, 46520
Hospital Lluis Alcanys; Servicio de Oncologia
Xativa, Valencia, Spain, 46800
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, Spain, 48013
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, Spain, 08024
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, Spain, 09006
Hospital San Pedro De Alcantara; Servicio de Oncologia
Caceres, Spain, 10003
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Spain, 12002
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, Spain, 17007
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, Spain, 18014
Hospital General Universitario de Guadalajara; Servicio de Oncologia
Guadalajara, Spain, 19002
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
Leon, Spain, 24071
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, Spain, 28033
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
Murcia, Spain, 30008
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, Spain, 30120
Hospital de Navarra; Servicio de Oncologia
Navarra, Spain, 31008
Complejo Hospitalario de Orense; Servicio de Oncologia
Orense, Spain, 32005
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, Spain, 46015
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
Valladolid, Spain, 47005
Hospital de Rio Hortega; Servicio de Oncologia
Valladolid, Spain, 47010
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Zamora, Spain, 49021
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sweden
Gävle Sjukhus; Onkologiska Kliniken
Gävle, Sweden, 80187
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Göteborg, Sweden, 413 45
Centralsjukhuset Karlstad, Onkologkliniken
Karlstad, Sweden, 65185
Skånes University Hospital, Skånes Department of Onclology
Lund, Sweden, 22185
Länssjukhuset Sundsvall, Onkologkliniken
Sundsvall, Sweden, 85186
Centrallasarettet Växjö, Onkologkliniken
Vaxjo, Sweden, 35185
Västmanlands sjukhus Västerås, Onkologkliniken
Västerås, Sweden, 72189
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, Turkey, 07070
Ege University Medical Faculty; Medical Oncology Department
Bornova, İ̇zmi̇r, Turkey, 35100
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey, 22770
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, Turkey, 25240
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, Turkey, 06100
Karadeniz Tecnical University Medical Faculty; Oncology Department
Trabzon, Turkey, 61080
Ukraine
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
Dnipropetrovsk, Ukraine, 49102
Kyiv City Clinical Oncological Center; Chemotherapy Department
Kiev, Ukraine, 03115
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
Lviv, Ukraine, 79031
Zaporozhye Regional Oncology Hospital; Dept of Oncology
Zaporozhye, Ukraine, 69104
United Arab Emirates
Tawam Hospital
Al Ain, United Arab Emirates, 15258
United Kingdom
Royal United Hospital; Oncology Department
Bath, United Kingdom, BA1 3NG
City Hospital NHS Trust
Birmingham, United Kingdom, B18 7QH
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford, United Kingdom, BD9 6RJ
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Addenbrookes Hospital; Dept of Oncology
Cambridge, United Kingdom, CB2 2QQ
Velindre Hospital
Cardiff, United Kingdom, CF14 2TL
Walsgrave Hospital
Coventry, United Kingdom, CV2 2DX
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
University Hospital of North Durham
Durham, United Kingdom, DH15TW
Hairmyres Hospital; Oncology Dept
East Kilbride, United Kingdom, G75 8RG
Eastbourne District Hospital; Department of Pharmacy
Eastbourne, United Kingdom, BN21 2UD
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Diana Princess of Wales Hosp.
Grimsby, United Kingdom, DN33 2BA
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
Leeds, United Kingdom, LS9 7TF
Huddersfield Royal Infirmary - Pharmacy department
Lindley, United Kingdom, HD3 3EA
Barts and the London NHS Trust.
London, United Kingdom, EC1A 7BE
Royal Free Hospital; Dept of Oncology
London, United Kingdom, NW3 2QG
Kings College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Royal Marsden Hospital - London
London, United Kingdom, SW3 6JJ
Macclesfield District General Hospital
Macclesfield, United Kingdom, SK10 3BL
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
James Cook Uni Hospital
Middlesborough, United Kingdom, TS4 3BW
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne, United Kingdom, NE7 7DN
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Peterborough City Hospital
Peterborough, United Kingdom, PE3 9GZ
Derriford Hospital; Plymouth Oncology Centre
Plymouth, United Kingdom, PL6 8DH
Musgrove Park Hospital
Somerset, United Kingdom, TA1 5DA
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LQ
Wishaw General Hospital
Wishaw, United Kingdom, ML2 0DP
Uruguay
Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología
Montevideo, Uruguay, 11400
Hospital Central De Las FF.AA.; Servicio De Oncologia
Montevideo, Uruguay, 11600
Hospital Pereira Rossell; Oncology Department
Montevideo, Uruguay, 11600
Venezuela
Instituto Oncológico Luis Razetti
Caracas, Venezuela, 1010
Centro Integral de Oncología
Caracas, Venezuela, 1060
Centro Médico Docente La Trinidad; Servicio de Gastroenterología
Caracas, Venezuela, 1080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01572038     History of Changes
Other Study ID Numbers: MO28047
2011-005334-20 ( EudraCT Number )
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Trastuzumab
Pertuzumab
Taxane
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological