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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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: March 22, 2012
Last updated: August 1, 2016
Last verified: August 2016
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted- and self-administered subcutaneous Herceptin (trastuzumab) as adjuvant therapy in patients with early HER2-positive breast cancer whose tumour has been excised. Patients will receive Herceptin 600 mg subcutaneously every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle (vial formulation, Cohort A) or with assisted- and self-administration using a single-use injection device (SID) in selected 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: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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 ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: approximately 8 years ]
  • Overall survival [ Time Frame: approximately 8 years ]
  • 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 ]

Enrollment: 2578
Study Start Date: May 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01566721

  Hide Study Locations
Tirana, Albania, 1000
Algiers, Algeria, 16000
Buenos Aires, Argentina, C1280AEB
Caba, Argentina, C1025ABI
Zarate, Argentina, 2800
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Kogarah, New South Wales, Australia, 2217
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Footscray, Victoria, Australia, 3011
Frankston, Victoria, Australia, 3199
Malvern, Victoria, Australia, 3144
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Salvador, BA, Brazil, 41253-190
Salvador, BA, Brazil, 41820-021
Porto Alegre, RS, Brazil, 90035-001
Jau, SP, Brazil, 17210-080
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01317-000
Sao Paulo, SP, Brazil, 01509-010
São Paulo, SP, Brazil, CEP 01321-001
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1303
Sofia, Bulgaria, 1784
Vratza, Bulgaria, 3000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Oshawa, Ontario, Canada, L1G 2B9
Toronto, Ontario, Canada, M5B 1W8
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Antofagasta, Chile, 1240000
Santiago, Chile, 8380000
Temuco, Chile, 4810469
Valparaiso, Chile, 2341391
Bogota, Colombia, 11001
Cali, Colombia
Osijek, Croatia, 31000
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 775 20
Praha 2, Czech Republic, 128 08
Praha 5, Czech Republic, 150 06
Dominican Republic
Santiago, Dominican Republic, 51000
Cuenca, Ecuador, EC010107
Guayaquil, Ecuador, EC090112
Quito, Ecuador, EC170124
Alexandria, Egypt, 11737
Cairo, Egypt, 11555
Cairo, Egypt, 11796
El Salvador
Salvador, El Salvador, 01101
Pori, Finland, 28500
Amiens, France, 80054
Besancon, France, 25030
Bordeaux, France, 33000
Bordeaux, France, 33077
Bourg En Bresse, France, 01012
Brest, France, 29200
Brive La Gaillarde, France, 19312
Chalon Sur Saone, France, 71100
Clermont Ferrand, France, 63011
Creteil, France, 94010
Dijon, France, 21000
Dijon, France, 21034
Draguignan, France, 83007
Guilherand Granges, France, 07500
Hyeres, France, 83400
La Roche Sur Yon, France, 85925
La Tronche, France, 38700
Le Mans, France, 72037
LeMans, France, 72000
Lille, France, 59000
Lille, France, 59037
Lorient, France, 56100
Lorient, France, 56322
Lyon, France, 69338
Marseille, France, 13285
Metz Tessy, France, 74370
Metz, France, 57000
Montpellier, France, 34070
Mougins, France, 06250
Neuilly-sur-seine, France, 92200
Nice, France, 06189
Paris, France, 75014
Paris, France, 75181
Paris, France, 75970
Pau, France, 64046
Pierre Benite, France, 69495
Saint Gregoire, France, 35768
Saint Herblain, France, 44805
Saint Jean, France, 31240
Saint Quentin, France, 02321
Saint-priest-en-jarez, France, 42270
St Martin Boulogne, France, 62280
Strasbourg, France, 67010
Strasbourg, France, 67065
Thonon Les Bains, France, 74203
Toulouse, France, 31059
Toulouse, France, 31076
Valenciennes, France, 59326
Vandoeuvre-les-Nancy, France, 54511
Augsburg, Germany, 86156
Bad Soden, Germany, 65812
Berlin, Germany, 10317
Berlin, Germany, 10967
Bielefeld, Germany, 33615
Bochum, Germany, 44787
Bremerhaven, Germany, 27574
Deggendorf, Germany, 94469
Dresden, Germany, 01307
Düsseldorf, Germany, 40625
Essen, Germany, 45122
Essen, Germany, 45136
Freiburg, Germany, 79106
Georgsmarienhütte, Germany, 49124
Gera, Germany, 07548
Halle, Germany, 06110
Hamburg, Germany, 20246
Hamburg, Germany, 20357
Hannover, Germany, 30177
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Jena, Germany, 07740
Kassel, Germany, 34117
Koeln, Germany, 50935
Kulmbach, Germany, 95326
Köln, Germany, 50679
Köln, Germany, 51067
Langen, Germany, 63225
Leverkusen, Germany, 51375
Ludwigsburg, Germany, 71640
Lübeck, Germany, 23538
Lübeck, Germany, 23562
Magdeburg, Germany, 39104
Mainz, Germany, 55131
Marburg, Germany, 35037
Meiningen, Germany, 98617
Memmingen, Germany, 87700
Minden, Germany, 32429
Muenchen, Germany, 80637
Mühlhausen, Germany, 99974
München, Germany, 80639
München, Germany, 81675
München, Germany, 81925
Münster, Germany, 48149
Neuruppin, Germany, 16816
Nürnberg, Germany, 90419
Offenbach, Germany, 63069
Ostfildern, Germany, 73760
Paderborn, Germany, 33098
Recklinghausen, Germany, 45657
Rotenburg-wuemme, Germany, 27356
Saarbruecken, Germany, 66113
Schweinfurt, Germany, 97422
Schwerin, Germany, 19049
Stendal, Germany, 39576
Stuttgart, Germany, 70190
Torgau, Germany, 04860
Tübingen, Germany, 72076
Unna, Germany, 59423
Weiden, Germany, 92637
Weinheim, Germany, 69469
Weißenfels, Germany, 06667
Wetzlar, Germany, 35578
Wuerselen, Germany, 52146
Alexandroupolis, Greece, 68100
Athens, Greece, 115 22
Athens, Greece, 115 27
Athens, Greece, 11528
Heraklion, Greece, 71110
Kifisia, Greece, 14564
Larissa, Greece, 41 110
Larissa, Greece, 41221
Thessaloniki, Greece, 546 45
Thessaloniki, Greece, 56429
Guatemala City, Guatemala, 01015
Guatemala, Guatemala, 01010
Hong Kong
Hong Kong, Hong Kong, 852
Shatin, Hong Kong
Budapest, Hungary, 1032
Budapest, Hungary, 1115
Budapest, Hungary, 1122
Budapest, Hungary, 1125
Debrecen, Hungary, 4032
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7623
Szombathely, Hungary, 9700
Bandung, Indonesia, 40161
Central Jakarta, Indonesia, 10430
East Java, Indonesia, 60286
Jakarta, Indonesia, 11420
Jogjakarta, Indonesia, 55284
Dublin 4, Ireland, 4
Dublin, Ireland, 7
Dublin, Ireland, 8
Dublin, Ireland, 9
Galway, Ireland
Limerick City, Ireland
Sligo, Ireland
Waterford, Ireland
Rionero in Vulture, Basilicata, Italy, 85028
Cosenza, Calabria, Italy, 87100
Napoli, Campania, Italy, 80131
Meldola, Emilia-Romagna, Italy, 47014
Parma, Emilia-Romagna, Italy, 43100
Piacenza, Emilia-Romagna, Italy, 29100
Ravenna, Emilia-Romagna, Italy, 48100
Frosinone, Lazio, Italy, 03100
Roma, Lazio, Italy, 00161
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00189
Viterbo, Lazio, Italy, 01100
Bergamo, Lombardia, Italy, 24128
Castellanza, Lombardia, Italy, 21053
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20133
Monza, Lombardia, Italy, 20900
Pavia, Lombardia, Italy, 27100
Rozzano, Lombardia, Italy, 20089
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70124
Brindisi, Puglia, Italy, 72100
Lecce, Puglia, Italy, 73100
San Giovanni Rotondo, Puglia, Italy, 71013
Cagliari, Sardegna, Italy, 09121
Sassari, Sardegna, Italy, 07100
Catania, Sicilia, Italy, 95100
Cefalù, Sicilia, Italy, 90015
Firenze, Toscana, Italy, 50139
Pisa, Toscana, Italy, 56100
Pontedera, Toscana, Italy, 56025
Camposampiero, Veneto, Italy, 35012
Cona (Ferrara), Veneto, Italy, 44124
Verona, Veneto, Italy, 37134
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 10408
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 08308
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Georgetown, Malaysia, 10990
Kuala Lumpur, Malaysia, 59100
Sabah, Malaysia, 88996
Sarawak, Malaysia, 93586
Campeche, Mexico, 24096
Chihuahua, Mexico, 31000
Distrito Federal, Mexico, 14080
Mexico City, Mexico, 03100
Mexico, Mexico, 06726
Oaxaca, Mexico, 68000
Queretaro, Queretaro, Mexico, 76090
Tepic, Mexico, 63170
Torreon, Mexico, 27000
Rabat, Morocco, 6213
'S Hertogenbosch, Netherlands, 5223 GZ
AC Amsterdam, Netherlands, 1091
Apeldoorn, Netherlands, 7334 DZ
Arnhem, Netherlands, 6815 AD
Dordrecht, Netherlands, 3318 AT
EDE, Netherlands, 6716 RP
Eindhoven, Netherlands, 5623 EJ
Eindhoven, Netherlands, 5631 BM
Groningen, Netherlands, 9728 NT
Heerlen, Netherlands, 6419 PC
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3430 EM
Roosendaal, Netherlands, 4708 AE
Rotterdam, Netherlands, 3078 HT
Rotterdam, Netherlands, 3083 AN
Schiedam, Netherlands, 3100 AE
Sittard-Geleen, Netherlands, 6162 BG
Utrecht, Netherlands, 3582 KE
Venlo, Netherlands, 5912 BL
Zaandam, Netherlands, 1502 DV
New Zealand
Tauranga, New Zealand, 3143
Kristiansand, Norway, 4604
Oslo, Norway, 0450
Stavanger, Norway, 4011
Islamabad, Pakistan, 44000
Karachi, Pakistan, 74800
Lahore, Pakistan, 54000
Lahore, Pakistan, 54600
Panama City, Panama, 083200752
Arequipa, Peru, 04001
Lima, Peru, 34
Lima, Peru, Lima 41
LIma, Peru, Lima27
Manila, Philippines, 1000
Quezon City, Philippines, 1100
Krakow, Poland, 31-531
Otwock, Poland, 05-400
Poznan, Poland, 60-569
Poznan, Poland, 61-866
Rzeszow, Poland, 35-021
Torun, Poland, 87-100
Zory, Poland, 44-240
Lisboa, Portugal, 1400-038
Lisboa, Portugal, 1500-650
Porto, Portugal, 4200-072
Porto, Portugal, 4200-319
Baia Mare, Romania, 430241
Bucharest, Romania, 010816
Bucharest, Romania, 022338
Bucharest, Romania, 050098
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
Cluj-Napoca, Romania, 400006
Craiova, Romania, 200385
Craiova, Romania, 200642
Iasi, Romania, 700106
Timisoara, Romania, 300167
Timisoara, Romania, 300239
Russian Federation
Irkutsk, Russian Federation, 664035
Izhevsk, Russian Federation, 426009
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Orenburg, Russian Federation, 460021
Saint-Petersburg, Russian Federation, 198255
UFA, Russian Federation, 450054
Saudi Arabia
Jeddah, Saudi Arabia, 21499
Riyadh, Saudi Arabia, 22490
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Nis, Serbia, 18000
Sremska Kamenica, Serbia, 21204
Singapore, Singapore, 169610
Banská Bystrica, Slovakia, 974 01
Bratislava, Slovakia, 811 05
Kosice, Slovakia, 04001
Presov, Slovakia, 081 81
Trencin, Slovakia, 911 71
Maribor, Slovenia, 2000
South Africa
Durban, South Africa, 4058
Johannesburg, South Africa, 2193
Pretoria, South Africa, 0002
Alcoy, Alicante, Spain, 03804
Elda, Alicante, Spain, 03600
Gijon, Asturias, Spain, 33394
Sabadell, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20014
Palma De Mallorca, Islas Baleares, Spain, 07014
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Vigo, Pontevedra, Spain, 36214
La Laguna, Tenerife, Spain, 38320
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Xativa, Valencia, Spain, 46800
Bilbao, Vizcaya, Spain, 48013
Albacete, Spain, 02006
Alicante, Spain, 3010
Barcelona, Spain, 08003
Barcelona, Spain, 08022
Barcelona, Spain, 08041
Barcelona, Spain, 08907
Barcelona, Spain, 08916
Burgos, Spain, 09006
Caceres, Spain, 10003
Jaen, Spain, 23007
Leon, Spain, 24071
Lerida, Spain, 25198
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28050
Madrid, Spain, 28223
Murcia, Spain, 30120
Navarra, Spain, 31008
Toledo, Spain, 45004
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Lund, Sweden, 22185
Skoevde, Sweden, 54185
Aarau, Switzerland, 5000
Baden, Switzerland, 5405
Bellinzona, Switzerland, 6500
Bern, Switzerland, 3010
Frauenfeld, Switzerland, 8501
Lausanne, Switzerland, 1011
Thun, Switzerland, 3600
Winterthur, Switzerland, 8401
Zürich, Switzerland, 8063
Taichung, Taiwan, 404
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Taipei, Taiwan, 114
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
Ankara, Turkey, 06590
Antalya, Turkey, 07070
Diyarbakir, Turkey, 21280
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34390
Istanbul, Turkey, 34890
Izmit, Turkey, 31380
Konya, Turkey, 42080
Mersin, Turkey, 33169
Samsun, Turkey, 55139
Sıhhiye, ANKARA, Turkey, 06100
Dnipropetrovsk, Ukraine, 49102
Kiev, Ukraine, 03115
Lviv, Ukraine, 79031
United Arab Emirates
Al Ain, United Arab Emirates, 15258
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Abergavenny, United Kingdom, NP7 7EG
Bedford, United Kingdom, MK42 9DJ
Belfast, United Kingdom, BT9 7AB
Berkshire, United Kingdom, SL2 4HL
Birmingham, United Kingdom, B15 2TH
Birmingham, United Kingdom, B9 5SS
Bournemouth, United Kingdom, BH7 7DW
Canterbury, United Kingdom, CT1 3NG
Chelmsford, United Kingdom, CM1 7ET
Colchester, United Kingdom, C03 3NB
Denbighshire, United Kingdom, LL185UJ
Derby, United Kingdom, DE22 3NE
Devon, United Kingdom, EX31 4JB
Dudley, United Kingdom, DY1 2HQ
Dundee, United Kingdom, DD12 9SY
Durham, United Kingdom, DH15TW
Glasgow, United Kingdom, G12 0YN
Greenock, United Kingdom, PA16 0XN
Grimsby, United Kingdom, DN33 2BA
Guildford, United Kingdom, GU2 7XX
Harlow, United Kingdom, CM20 1QX
Huddersfield, United Kingdom, HD3 3EA
Ipswich, United Kingdom, IP4 5PD
Kilmarnock, United Kingdom, KA2 0BE
Larbert, United Kingdom, FK5 4QE
Leicester, United Kingdom, LE1 5WW
Livingston, United Kingdom, EH54 6PP
London, United Kingdom, SE1 9RT
London, United Kingdom, SE18 4QH
London, United Kingdom, SW17 0QT
Macclesfield, United Kingdom, SK10 3BL
Manchester, United Kingdom, M20 4QL
New Castle upon Tyne, United Kingdom, NE7 7DN
Newport, United Kingdom, NP20 2UB
North Shields, United Kingdom, NE29 8NH
Northampton, United Kingdom, NN1 5BD
Plymouth, United Kingdom, PL6 8DH
Poole, United Kingdom, BH15 2JB
Portsmouth, United Kingdom, PO6 3LY
Preston, United Kingdom, PR2 9HT
Romford, United Kingdom, RM7 0AE
Scarborough, United Kingdom, YO12 6QL
Shrewsbury, United Kingdom, SY3 8XQ
Southampton, United Kingdom, SO16 6YD
Sunderland, United Kingdom, SR4 7TP
Swansea, United Kingdom, SA2 8QA
Swindon, United Kingdom, SN3 6BB
Truro, United Kingdom, TR1 3LJ
Winchester, United Kingdom, SO22 5DG
Wirral, United Kingdom, CH63 4JY
Wolverhampton, United Kingdom, WV10 0QP
York, United Kingdom, BD20 6TD
York, United Kingdom, YO31 8HE
Montevideo, Uruguay, 11400
Montevideo, Uruguay, 11600
Caracas, Venezuela, 1010
Caracas, Venezuela, 1020
Caracas, Venezuela, 1060
Caracas, Venezuela, 1080
Hanoi, Vietnam, 70000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01566721     History of Changes
Other Study ID Numbers: MO28048
2011-005328-17 ( EudraCT Number )
Study First Received: March 22, 2012
Last Updated: August 1, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on March 29, 2017