A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01566721
First received: March 22, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted- and self-administered subcutaneous Hercept in (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg su bcutaneously every 3 weeks for 18 cycles, either by an assisted administration u sing a conventional syringe and needle (vial formulation, Cohort A) or with assi sted- and self-administration using a single-use injection device (SID) in selec ted patients (Cohort B). Anticipated time on study treatment is up to 1 year.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SafeHer Study]

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Patient satisfaction with trastuzumab SC using the single-use injection device (SID): SID satisfaction questionnaire (patients in cohort B who went on to self-administration of the study drug) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A: vial formulation Drug: trastuzumab [Herceptin]
600 mg sc by assisted administration using the vial formulation, into thigh, on Day 1 of each 3-week cycle, 18 cycles
Experimental: Cohort B: SID Drug: trastuzumab [Herceptin]
600 mg sc by single-use injection device (SID) and by self-administration in select patients, into thigh, on Day 1 of each 3-week cycle, 18 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients, >/= 18 years of age
  • Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I to IIIC that is eligible for adjuvant treatment with trastuzumab
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) >/= 55%

Exclusion Criteria:

  • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
  • History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
  • Past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
  • Metastatic disease
  • Inadequate bone marrow, hepatic or renal function
  • Serious cardiac or cardiovascular disease
  • Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
  • History of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566721

Contacts
Contact: Reference Study ID Number: MO28048 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
Albania
Active, not recruiting
Tirana, Albania, 1000
Algeria
Active, not recruiting
Algiers, Algeria, 16000
Argentina
Active, not recruiting
Buenos Aires, Argentina, C1280AEB
Active, not recruiting
Caba, Argentina, C1050AAK
Active, not recruiting
Zarate, Argentina, 2800
Australia, New South Wales
Active, not recruiting
Adelaide, New South Wales, Australia, 5011
Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Active, not recruiting
Kogarah, New South Wales, Australia, 2217
Active, not recruiting
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Active, not recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Active, not recruiting
Footscray, Victoria, Australia, 3011
Active, not recruiting
Frankston, Victoria, Australia, 3199
Active, not recruiting
Malvern, Victoria, Australia, 3144
Completed
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Recruiting
Perth, Western Australia, Australia, 6000
Bosnia and Herzegovina
Active, not recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Active, not recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Active, not recruiting
Salvador, BA, Brazil, 41820-021
Active, not recruiting
Salvador, BA, Brazil, 41253-190
Active, not recruiting
Porto Alegre, RS, Brazil, 90035-001
Active, not recruiting
Jau, SP, Brazil, 17210-080
Completed
Sao Paulo, SP, Brazil, 01321-001
Completed
Sao Paulo, SP, Brazil, 01509-010
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Bulgaria
Active, not recruiting
Plovdiv, Bulgaria, 4004
Active, not recruiting
Sofia, Bulgaria, 1784
Active, not recruiting
Sofia, Bulgaria, 1303
Canada, Alberta
Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Active, not recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Active, not recruiting
Oshawa, Ontario, Canada, L1G 2B9
Active, not recruiting
Toronto, Ontario, Canada, M5B 1W8
Active, not recruiting
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Terminated
Montreal, Quebec, Canada, H1T 2M4
Chile
Active, not recruiting
Antofagasta, Chile, 1240000
Active, not recruiting
Santiago, Chile, 8380000
Active, not recruiting
Temuco, Chile, 4810469
Active, not recruiting
Valparaiso, Chile, 2341391
Colombia
Active, not recruiting
Bogota, Colombia, 11001
Active, not recruiting
Cali, Colombia
Croatia
Active, not recruiting
Osijek, Croatia, 31000
Active, not recruiting
Zagreb, Croatia, 10000
Czech Republic
Active, not recruiting
Brno, Czech Republic, 656 53
Active, not recruiting
Olomouc, Czech Republic, 775 20
Completed
Praha, Czech Republic, 128 08
Active, not recruiting
Praha 5, Czech Republic, 150 06
Dominican Republic
Active, not recruiting
Santiago, Dominican Republic, 51000
Ecuador
Active, not recruiting
Cuenca, Ecuador, EC010107
Active, not recruiting
Guayaquil, Ecuador, EC090112
Active, not recruiting
Quito, Ecuador, EC170124
Egypt
Active, not recruiting
Alexandria, Egypt, 11737
Active, not recruiting
Cairo, Egypt, 11555
Active, not recruiting
Cairo, Egypt, 11796
El Salvador
Active, not recruiting
Salvador, El Salvador, 01101
Finland
Completed
Pori, Finland, 28500
France
Active, not recruiting
Amiens, France, 80054
Active, not recruiting
Besancon, France, 25030
Active, not recruiting
Bordeaux, France, 33000
Active, not recruiting
Bordeaux, France, 33077
Active, not recruiting
Bourg En Bresse, France, 01012
Active, not recruiting
Brest, France, 29200
Active, not recruiting
Brive La Gaillarde, France, 19312
Active, not recruiting
Chalon Sur Saone, France, 71100
Active, not recruiting
Clermont Ferrand, France, 63011
Completed
Creteil, France, 94010
Active, not recruiting
Dijon, France, 21000
Active, not recruiting
Dijon, France, 21034
Active, not recruiting
Draguignan, France, 83007
Active, not recruiting
Guilherand Granges, France, 07500
Active, not recruiting
Hyeres, France, 83400
Completed
La Roche Sur Yon, France, 85925
Active, not recruiting
La Tronche, France, 38700
Active, not recruiting
Le Mans, France, 72037
Active, not recruiting
LeMans, France, 72000
Not yet recruiting
Libourne, France, 33505
Active, not recruiting
Lille, France, 59000
Active, not recruiting
Lille, France, 59037
Active, not recruiting
Lorient, France, 56100
Active, not recruiting
Lorient, France, 56322
Active, not recruiting
Lyon, France, 69338
Active, not recruiting
Marseille, France, 13285
Active, not recruiting
Metz, France, 57072
Active, not recruiting
Metz Tessy, France, 74370
Active, not recruiting
Montpellier, France, 34070
Active, not recruiting
Mougins, France, 06250
Completed
Neuilly-sur-seine, France, 92200
Active, not recruiting
Nice, France, 06189
Completed
Paris, France, 75181
Active, not recruiting
Paris, France, 75679
Active, not recruiting
Paris, France, 75970
Active, not recruiting
Pau, France, 64046
Active, not recruiting
Pierre Benite, France, 69495
Completed
Saint Gregoire, France, 35768
Active, not recruiting
Saint Herblain, France, 44805
Active, not recruiting
Saint Jean, France, 31240
Active, not recruiting
Saint Quentin, France, 02321
Active, not recruiting
Saint-priest-en-jarez, France, 42270
Active, not recruiting
St Martin Boulogne, France, 62280
Completed
Strasbourg, France, 67065
Completed
Strasbourg, France, 67010
Active, not recruiting
Thonon Les Bains, France, 74203
Active, not recruiting
Toulouse, France, 31059
Active, not recruiting
Toulouse, France, 31076
Completed
Valenciennes, France, 59326
Active, not recruiting
Vandoeuvre-les-Nancy, France, 54511
Germany
Active, not recruiting
Augsburg, Germany, 86156
Active, not recruiting
Bad Soden, Germany, 65812
Active, not recruiting
Berlin, Germany, 10317
Active, not recruiting
Berlin, Germany, 10967
Active, not recruiting
Bielefeld, Germany, 33615
Active, not recruiting
Bochum, Germany, 44787
Terminated
Bremerhaven, Germany, 27574
Active, not recruiting
Deggendorf, Germany, 94469
Terminated
Dresden, Germany, 01307
Terminated
Düsseldorf, Germany, 40625
Active, not recruiting
Essen, Germany, 45122
Active, not recruiting
Essen, Germany, 45136
Active, not recruiting
Freiburg, Germany, 79106
Active, not recruiting
Georgsmarienhütte, Germany, 49124
Terminated
Gera, Germany, 07548
Active, not recruiting
Halle, Germany, 06110
Recruiting
Hamburg, Germany, 20246
Active, not recruiting
Hamburg, Germany, 20357
Active, not recruiting
Hannover, Germany, 30177
Active, not recruiting
Hannover, Germany, 30625
Active, not recruiting
Heidelberg, Germany, 69120
Active, not recruiting
Jena, Germany, 07740
Active, not recruiting
Kassel, Germany, 34117
Active, not recruiting
Koeln, Germany, 50935
Active, not recruiting
Kulmbach, Germany, 95326
Active, not recruiting
Köln, Germany, 50679
Active, not recruiting
Köln, Germany, 51067
Active, not recruiting
Langen, Germany, 63225
Active, not recruiting
Leverkusen, Germany, 51375
Active, not recruiting
Ludwigsburg, Germany, 71640
Active, not recruiting
Lübeck, Germany, 23562
Active, not recruiting
Lübeck, Germany, 23538
Terminated
Magedburg, Germany, 39104
Active, not recruiting
Mainz, Germany, 55131
Active, not recruiting
Marburg, Germany, 35037
Active, not recruiting
Meiningen, Germany, 98617
Active, not recruiting
Memmingen, Germany, 87700
Active, not recruiting
Minden, Germany, 32429
Terminated
Muenchen, Germany, 80637
Active, not recruiting
Mühlhausen, Germany, 99974
Active, not recruiting
München, Germany, 81925
Terminated
München, Germany, 81675
Active, not recruiting
München, Germany, 80639
Active, not recruiting
Münster, Germany, 48149
Active, not recruiting
Neuruppin, Germany, 16816
Active, not recruiting
Nuernberg, Germany, 90419
Active, not recruiting
Offenbach, Germany, 63069
Completed
Ostfildern, Germany, 73760
Terminated
Paderborn, Germany, 33098
Active, not recruiting
Recklinghausen, Germany, 45657
Active, not recruiting
Rotenburg-wuemme, Germany, 27356
Active, not recruiting
Saarbruecken, Germany, 66113
Active, not recruiting
Schweinfurt, Germany, 97422
Active, not recruiting
Schwerin, Germany, 19049
Active, not recruiting
Stendal, Germany, 39576
Terminated
Stuttgart, Germany, 70190
Active, not recruiting
Torgau, Germany, 04860
Active, not recruiting
Tübingen, Germany, 72076
Active, not recruiting
Unna, Germany, 59423
Terminated
Weiden, Germany, 92637
Active, not recruiting
Weinheim, Germany, 69469
Active, not recruiting
Weißenfels, Germany, 06667
Active, not recruiting
Wetzlar, Germany, 35578
Active, not recruiting
Wuerselen, Germany, 52146
Greece
Active, not recruiting
Alexandroupolis, Greece, 68100
Active, not recruiting
Athens, Greece, 11528
Active, not recruiting
Athens, Greece, 11522
Active, not recruiting
Athens, Greece, 115 27
Active, not recruiting
Heraklion, Greece, 71110
Active, not recruiting
Kifisia, Greece, 14564
Active, not recruiting
Larissa, Greece, 41 110
Terminated
Larissa, Greece, 41221
Active, not recruiting
Thessaloniki, Greece, 54645
Active, not recruiting
Thessaloniki, Greece, 56429
Guatemala
Active, not recruiting
Guatemala, Guatemala, 01009
Active, not recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong
Hungary
Active, not recruiting
Budapest, Hungary, 1122
Active, not recruiting
Budapest, Hungary, 1032
Active, not recruiting
Budapest, Hungary, 1115
Active, not recruiting
Budapest, Hungary, 1125
Active, not recruiting
Debrecen, Hungary, 4032
Active, not recruiting
Nyíregyháza, Hungary, 4400
Active, not recruiting
Pecs, Hungary, 7624
Active, not recruiting
Szombathely, Hungary, 9700
Indonesia
Active, not recruiting
Bandung, Indonesia, 40161
Active, not recruiting
Central Jakarta, Indonesia, 10430
Active, not recruiting
East Java, Indonesia, 60286
Active, not recruiting
Jakarta, Indonesia, 11420
Active, not recruiting
Jogjakarta, Indonesia, 55284
Ireland
Active, not recruiting
Dublin, Ireland, 7
Active, not recruiting
Dublin, Ireland, 9
Completed
Dublin, Ireland, 8
Completed
Dublin, Ireland, 4
Recruiting
Dublin, Ireland, 7
Completed
Galway, Ireland
Active, not recruiting
Limerick City, Ireland
Recruiting
Sligo, Ireland
Active, not recruiting
Waterford, Ireland
Italy
Recruiting
Rionero in Vulture, Basilicata, Italy, 85028
Completed
Cosenza, Calabria, Italy, 87100
Active, not recruiting
Napoli, Campania, Italy, 80131
Recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Meldola, Emilia-Romagna, Italy, 47014
Active, not recruiting
Parma, Emilia-Romagna, Italy, 43100
Active, not recruiting
Piacenza, Emilia-Romagna, Italy, 29100
Recruiting
Ravenna, Emilia-Romagna, Italy, 48100
Active, not recruiting
Frosinone, Lazio, Italy, 03100
Not yet recruiting
Latina, Lazio, Italy, 4100
Active, not recruiting
Roma, Lazio, Italy, 00168
Recruiting
Roma, Lazio, Italy, 00189
Completed
Roma, Lazio, Italy, 00161
Active, not recruiting
Viterbo, Lazio, Italy, 01100
Active, not recruiting
Bergamo, Lombardia, Italy, 24128
Completed
Castellanza, Lombardia, Italy, 21053
Active, not recruiting
Cremona, Lombardia, Italy, 26100
Active, not recruiting
Milano, Lombardia, Italy, 20133
Active, not recruiting
Monza, Lombardia, Italy, 20052
Active, not recruiting
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Rozzano, Lombardia, Italy, 20089
Completed
Novara, Piemonte, Italy, 28100
Active, not recruiting
Torino, Piemonte, Italy, 10126
Active, not recruiting
Bari, Puglia, Italy, 70124
Completed
Brindisi, Puglia, Italy, 72100
Active, not recruiting
Lecce, Puglia, Italy, 73100
Active, not recruiting
San Giovanni Rotondo, Puglia, Italy, 71013
Active, not recruiting
Cagliari, Sardegna, Italy, 09121
Active, not recruiting
Sassari, Sardegna, Italy, 07100
Active, not recruiting
Catania, Sicilia, Italy, 95100
Completed
Cefalù, Sicilia, Italy, 90015
Not yet recruiting
Ragusa, Sicilia, Italy, 97100
Not yet recruiting
Taormina, Sicilia, Italy, 98030
Active, not recruiting
Firenze, Toscana, Italy, 50139
Active, not recruiting
Pisa, Toscana, Italy, 56100
Active, not recruiting
Pontedera, Toscana, Italy, 56025
Active, not recruiting
Camposampiero, Veneto, Italy, 35012
Active, not recruiting
Cona (Ferrara), Veneto, Italy, 44124
Completed
Verona, Veneto, Italy, 37134
Korea, Republic of
Active, not recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Active, not recruiting
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 152-703
Recruiting
Seoul, Korea, Republic of, 120-752
Active, not recruiting
Seoul, Korea, Republic of, 138-736
Lithuania
Active, not recruiting
Kaunas, Lithuania, 50009
Active, not recruiting
Klaipeda, Lithuania, 92288
Malaysia
Active, not recruiting
Georgetown, Malaysia, 10990
Active, not recruiting
Kuala Lumpur, Malaysia, 59100
Active, not recruiting
Sabah, Malaysia, 88996
Active, not recruiting
Sarawak, Malaysia, 93586
Mexico
Active, not recruiting
Campeche, Mexico, 24096
Active, not recruiting
Chihuahua, Mexico, 31000
Active, not recruiting
DF, Mexico, 04110
Active, not recruiting
Distrito Federal, Mexico, 14080
Terminated
Mexico, Mexico, 06726
Active, not recruiting
Oaxaca, Mexico, 68000
Active, not recruiting
Queretaro, Mexico, 76178
Active, not recruiting
Tepic, Mexico, 63170
Completed
Torreon, Mexico, 27000
Morocco
Active, not recruiting
Rabat, Morocco, 6213
Netherlands
Active, not recruiting
'S Hertogenbosch, Netherlands, 5223 GZ
Active, not recruiting
AC Amsterdam, Netherlands, 1091
Active, not recruiting
Apeldoorn, Netherlands, 7334 DZ
Active, not recruiting
Arnhem, Netherlands, 6815 AD
Active, not recruiting
Dordrecht, Netherlands, 3318 AT
Active, not recruiting
EDE, Netherlands, 6716 RP
Active, not recruiting
Eindhoven, Netherlands, 5631 BM
Active, not recruiting
Eindhoven, Netherlands, 5623 EJ
Active, not recruiting
Groningen, Netherlands, 9728 NT
Active, not recruiting
Heerlen, Netherlands, 6419 PC
Active, not recruiting
Hoofddorp, Netherlands, 2134 TM
Active, not recruiting
Nieuwegein, Netherlands, 3430 EM
Active, not recruiting
Roosendaal, Netherlands, 4708 AE
Active, not recruiting
Rotterdam, Netherlands, 3078 HT
Active, not recruiting
Rotterdam, Netherlands, 3083 AN
Active, not recruiting
Schiedam, Netherlands, 3100 AE
Active, not recruiting
Sittard-Geleen, Netherlands, 6162 BG
Active, not recruiting
Utrecht, Netherlands, 3582 KE
Active, not recruiting
Venlo, Netherlands, 5912 BL
Active, not recruiting
Zaandam, Netherlands, 1502 DV
New Zealand
Active, not recruiting
Tauranga, New Zealand, 3143
Norway
Active, not recruiting
Kristiansand, Norway, 4604
Active, not recruiting
Oslo, Norway, 0450
Active, not recruiting
Stavanger, Norway, 4011
Pakistan
Active, not recruiting
Islamabad, Pakistan, 44000
Active, not recruiting
Karachi, Pakistan, 74800
Active, not recruiting
Lahore, Pakistan, 54600
Active, not recruiting
Lahore, Pakistan, 54000
Panama
Active, not recruiting
Panama City, Panama, 32400
Peru
Active, not recruiting
Arequipa, Peru, 04001
Active, not recruiting
Lima, Peru, 34
Active, not recruiting
LIma, Peru, Lima27
Active, not recruiting
Lima, Peru, Lima 41
Philippines
Active, not recruiting
Manila, Philippines, 1000
Active, not recruiting
Quezon City, Philippines, 1100
Poland
Active, not recruiting
Krakow, Poland, 31-531
Active, not recruiting
Otwock, Poland, 05-400
Active, not recruiting
Poznan, Poland, 61-866
Active, not recruiting
Poznan, Poland, 60-569
Active, not recruiting
Rzeszow, Poland, 35-021
Active, not recruiting
Torun, Poland, 87-100
Active, not recruiting
Zory, Poland, 44-240
Portugal
Active, not recruiting
Lisboa, Portugal, 1400-038
Active, not recruiting
Lisboa, Portugal, 1500-650
Active, not recruiting
Porto, Portugal, 4200-319
Active, not recruiting
Porto, Portugal, 4200-072
Romania
Completed
Baia Mare, Romania, 430241
Active, not recruiting
Bucharest, Romania, 050098
Completed
Bucharest, Romania, 010816
Completed
Bucharest, Romania, 022338
Active, not recruiting
Bucuresti, Romania, 022328
Active, not recruiting
Cluj Napoca, Romania, 400015
Completed
Cluj Napoca, Romania, 400015
Active, not recruiting
Cluj-Napoca, Romania, 400006
Active, not recruiting
Craiova, Romania, 200642
Active, not recruiting
Craiova, Romania, 200385
Completed
Iasi, Romania, 700106
Active, not recruiting
Timisoara, Romania, 300239
Active, not recruiting
Timisoara, Romania, 300167
Russian Federation
Active, not recruiting
Irkutsk, Russian Federation, 664035
Active, not recruiting
Izhevsk, Russian Federation, 426009
Active, not recruiting
Moscow, Russian Federation, 115478
Active, not recruiting
Moscow, Russian Federation, 143423
Active, not recruiting
Orenburg, Russian Federation, 460021
Active, not recruiting
Saint-Petersburg, Russian Federation, 198255
Active, not recruiting
UFA, Russian Federation, 450054
Saudi Arabia
Active, not recruiting
Jeddah, Saudi Arabia, 21499
Active, not recruiting
Riyadh, Saudi Arabia, 22490
Serbia
Active, not recruiting
Belgrade, Serbia, 11000
Active, not recruiting
Kragujevac, Serbia, 34000
Active, not recruiting
Nis, Serbia, 18000
Active, not recruiting
Sremska Kamenica, Serbia, 21204
Singapore
Active, not recruiting
Singapore, Singapore, 169610
Slovakia
Active, not recruiting
Banská Bystrica, Slovakia, 974 01
Active, not recruiting
Bratislava, Slovakia, 811 05
Active, not recruiting
Kosice, Slovakia, 04001
Recruiting
Presov, Slovakia, 081 81
Recruiting
Trencin, Slovakia, 911 71
Slovenia
Active, not recruiting
Maribor, Slovenia, 2000
South Africa
Active, not recruiting
Durban, South Africa, 4058
Active, not recruiting
Johannesburg, South Africa, 2193
Active, not recruiting
Pretoria, South Africa, 0002
Spain
Completed
Alcoy, Alicante, Spain, 03804
Active, not recruiting
Elda, Alicante, Spain, 03600
Active, not recruiting
Gijon, Asturias, Spain, 33394
Active, not recruiting
Sabadell, Barcelona, Barcelona, Spain, 08208
Active, not recruiting
Santander, Cantabria, Spain, 39008
Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20014
Active, not recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Active, not recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Active, not recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Active, not recruiting
Vigo, Pontevedra, Spain, 36214
Active, not recruiting
La Laguna, Tenerife, Spain, 38320
Active, not recruiting
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Active, not recruiting
Xativa, Valencia, Spain, 46800
Active, not recruiting
Bilbao, Vizcaya, Spain, 48013
Active, not recruiting
Albacete, Spain, 02006
Active, not recruiting
Alicante, Spain, 3010
Recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08022
Active, not recruiting
Barcelona, Spain, 08907
Active, not recruiting
Barcelona, Spain, 08041
Active, not recruiting
Barcelona, Spain, 08916
Active, not recruiting
Burgos, Spain, 09006
Active, not recruiting
Caceres, Spain, 10003
Active, not recruiting
Jaen, Spain, 23007
Recruiting
Leon, Spain, 24071
Active, not recruiting
Lerida, Spain, 25198
Active, not recruiting
Madrid, Spain, 28223
Active, not recruiting
Madrid, Spain, 28034
Active, not recruiting
Madrid, Spain, 28050
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Murcia, Spain, 30120
Active, not recruiting
Navarra, Spain, 31008
Active, not recruiting
Toledo, Spain, 45004
Active, not recruiting
Valencia, Spain, 46015
Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Active, not recruiting
Lund, Sweden, 22185
Active, not recruiting
Skoevde, Sweden, 54185
Switzerland
Active, not recruiting
Aarau, Switzerland, 5000
Active, not recruiting
Baden, Switzerland, 5405
Active, not recruiting
Bellinzona, Switzerland, 6500
Active, not recruiting
Bern, Switzerland, 3010
Recruiting
Frauenfeld, Switzerland, 8501
Active, not recruiting
Lausanne, Switzerland, 1011
Active, not recruiting
Thun, Switzerland, 3600
Active, not recruiting
Winterthur, Switzerland, 8401
Active, not recruiting
Zürich, Switzerland, 8063
Taiwan
Active, not recruiting
Taichung, Taiwan, 404
Active, not recruiting
Tainan, Taiwan, 704
Active, not recruiting
Taipei, Taiwan, 100
Active, not recruiting
Taipei, Taiwan, 114
Thailand
Active, not recruiting
Bangkok, Thailand, 10400
Active, not recruiting
Bangkok, Thailand, 10330
Recruiting
Bangkok, Thailand, 10400
Active, not recruiting
Chiang Mai, Thailand, 50200
Turkey
Active, not recruiting
Ankara, Turkey, 06590
Active, not recruiting
Antalya, Turkey, 07070
Active, not recruiting
Diyarbakir, Turkey, 21280
Active, not recruiting
Gaziantep, Turkey, 27310
Active, not recruiting
Istanbul, Turkey, 34890
Active, not recruiting
Istanbul, Turkey, 34390
Active, not recruiting
Izmit, Turkey, 41380
Terminated
Konya, Turkey, 42080
Active, not recruiting
Mersin, Turkey, 33169
Active, not recruiting
S?hhiye, ANKARA, Turkey, 06100
Active, not recruiting
Samsun, Turkey, 55139
Ukraine
Terminated
Dnipropetrovsk, Ukraine, 49102
Active, not recruiting
Kiev, Ukraine, 03115
Active, not recruiting
Lviv, Ukraine, 79031
United Arab Emirates
Active, not recruiting
Al Ain, United Arab Emirates, 15258
United Kingdom
Terminated
Aberdeen, United Kingdom, AB25 2ZN
Active, not recruiting
Abergavenny, United Kingdom, NP7 7EG
Active, not recruiting
Bedford, United Kingdom, MK42 9DJ
Terminated
Belfast, United Kingdom, BT9 7AB
Active, not recruiting
Berkshire, United Kingdom, SL2 4HL
Active, not recruiting
Birmingham, United Kingdom, B15 2TH
Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Active, not recruiting
Bournemouth, United Kingdom, BH7 7DW
Active, not recruiting
Canterbury, United Kingdom, CT1 3NG
Active, not recruiting
Chelmsford, United Kingdom, CM1 7ET
Completed
Colchester, United Kingdom, C03 3NB
Active, not recruiting
Denbighshire, United Kingdom, LL185UJ
Active, not recruiting
Derby, United Kingdom, DE22 3NE
Active, not recruiting
Devon, United Kingdom, EX31 4JB
Active, not recruiting
Dudley, United Kingdom, DY1 2HQ
Terminated
Dundee, United Kingdom, DD12 9SY
Active, not recruiting
Durham, United Kingdom, DH15TW
Active, not recruiting
Glasgow, United Kingdom, G12 0YN
Active, not recruiting
Greenock, United Kingdom, PA16 0XN
Active, not recruiting
Grimsby, United Kingdom, DN33 2BA
Active, not recruiting
Guildford, United Kingdom, GU2 7XX
Active, not recruiting
Harlow, United Kingdom, CM20 1QX
Active, not recruiting
Huddersfield, United Kingdom, HD3 3EA
Active, not recruiting
Ipswich, United Kingdom, IP4 5PD
Active, not recruiting
Kilmarnock, United Kingdom, KA2 0BE
Active, not recruiting
Larbert, United Kingdom, FK5 4QE
Active, not recruiting
Leicester, United Kingdom, LE1 5WW
Active, not recruiting
Livingston, United Kingdom, EH54 6PP
Active, not recruiting
London, United Kingdom, SE1 9RT
Active, not recruiting
London, United Kingdom, SW17 0QT
Active, not recruiting
London, United Kingdom, SE18 4QH
Active, not recruiting
Macclesfield, United Kingdom, SK10 3BL
Active, not recruiting
Manchester, United Kingdom, M20 4BX
Active, not recruiting
Newcastle Upon Tyne, United Kingdom, NE4 6BE
Completed
Newport, United Kingdom, NP20 2UB
Active, not recruiting
North Shields, United Kingdom, NE29 8NH
Active, not recruiting
Northampton, United Kingdom, NN1 5BD
Active, not recruiting
Plymouth, United Kingdom, PL6 8DH
Active, not recruiting
Poole, United Kingdom, BH15 2JB
Active, not recruiting
Portsmouth, United Kingdom, PO6 3LY
Active, not recruiting
Preston, United Kingdom, PR2 9HT
Active, not recruiting
Romford, United Kingdom, RM7 0AE
Completed
Scarborough, United Kingdom, YO12 6QL
Active, not recruiting
Shrewsbury, United Kingdom, SY3 8XQ
Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Active, not recruiting
Sunderland, United Kingdom, SR4 7TP
Active, not recruiting
Swansea, United Kingdom, SA2 8QA
Active, not recruiting
Swindon, United Kingdom, SN3 6BB
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Active, not recruiting
Winchester, United Kingdom, SO22 5DG
Active, not recruiting
Wirral, United Kingdom, CH63 4JY
Active, not recruiting
Wolverhampton, United Kingdom, WV10 0QP
Active, not recruiting
York, United Kingdom, BD20 6TD
Active, not recruiting
York, United Kingdom, YO31 8HE
Uruguay
Active, not recruiting
Montevideo, Uruguay, 11400
Active, not recruiting
Montevideo, Uruguay, 11600
Venezuela
Active, not recruiting
Caracas, Venezuela, 1060
Completed
Caracas, Venezuela, 1020
Active, not recruiting
Caracas, Venezuela, 1080
Active, not recruiting
Caracas, Venezuela, 1010
Vietnam
Active, not recruiting
Hanoi, Vietnam, 70000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01566721     History of Changes
Other Study ID Numbers: MO28048, 2011-005328-17
Study First Received: March 22, 2012
Last Updated: July 28, 2014
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014