Breast NeoplasmsPhase 3SafeHERNCT01566721
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
A Phase 3 study testing Herceptin in people with Breast Neoplasms, run by Hoffmann-La Roche at 437 sites in 59 countries.
Trial summary
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,577 participants
- Where
- 437 sitesin 59 countries
- Study dates
- 17 May 2012to 19 Feb 2020
- Phase
- Phase 3
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 treatment with Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Who cannot join
- 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, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- Metastatic disease
- Inadequate bone marrow, hepatic, or renal function
- Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of severe allergic or immunological reactions, such as difficult-to-control asthma
- Pregnant or lactating women
Trial locations and contacts
437 sites in 59 countries.
437 sites in 59 countries
Germany54 sites
Klinikum Augsburg; Frauenklinik
Augsburg, 86156
Internist; Praxis Für Haemotologie & Onkologie
Bad Soden, 65812
Praxis Dres. Schilling & Till
Berlin, 10317
Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen
Berlin, 10967
Katholische Hospitalvereinigung Ostwestfalen gGmbH
Bielefeld, 33615
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
Bochum, 44787
Praxis Dr.med. Katja Ziegler-Löhr
Cologne, 50679
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
Cologne, 50935
Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum
Cologne, 51067
DONAU ISAR Klinikum Deggendorf; Frauenklinik
Deggendorf, 94469
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, 45122
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136
Universitätsklinikum Freiburg; Frauenklinik
Freiburg im Breisgau, 79106
Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe
Georgsmarienhütte, 49124
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe
Halle, 06110
Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie
Hamburg, 20246
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hanover, 30177
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hanover, 30625
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Jena, 07747
Elisabeth-Krankenhaus Brustzentrum
Kassel, 34117
Klinikum Kulmbach; Frauenklinik
Kulmbach, 95326
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen, 51375
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562
Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe
Ludwigsburg, 71640
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, 35037
Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
Meiningen, 98617
Klinikum Memmingen; Abt.Gynäkologie
Memmingen, 87700
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
Minden, 32429
Praxis Dr.med. Steffi Busch
Mühlhausen, 99974
Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer
München, 80638
Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik
München, 81925
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, 48149
Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe
Neuruppin, 16816
Klinikum Nord Frauenklinik
Nuremberg, 90419
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach, 63069
medius KLINIK OSTFILDERN-RUIT; Brustzentrum
Ostfildern, 73760
Oncologianova GmbH
Recklinghausen, 45659
Agaplesion Diakonieklinikum Rotenburg
Rotenburg (Wümme), 27356
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, 66113
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH
Schweinfurt, 97422
HELIOS Klinikum Schwerin; Frauenklinik
Schwerin, 19049
Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe
Stendal, 39576
Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe
Torgau, 04860
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076
Katharinen-Hospital gGmbH
Unna, 59423
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
Weinheim, 69469
ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH
Weißenfels, 06667
Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe
Wetzlar, 35578
Gesellschaft für Medizinische Studien Würselen
Würselen, 52146
United Kingdom50 sites
Nevill Hall Hospital
Abergavenny, NP7 7EG
Bedford Hospital; Oncology
Bedford, MK42 9DJ
Wexham Park Hospital; Oncology
Berkshire, SL2 4HL
University Hospital Birmingham Queen Elizabeth Hospital
Birmingham, B17 0NH
Heartlands Hospital; Department Of Medicine
Birmingham, B9 5SS
Royal Bournemouth Hospital; Oncology
Bournemouth, BH7 7DW
Kent & Canterbury Hospital
Canterbury, CT1 3NG
Broomfield Hospital; Oncology
Chelmsford, CM1 7ET
Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr
Denbighshire, LL18 5UJ
Royal Derby Hospital
Derby, DE22 3NE
North Devon District Hospital
Devon, EX31 4JB
Russells Hall Hospital; Oncology
Dudley, DY1 2HQ
University Hospital of North Durham
Durham, DH15TW
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Inverclyde Hospital
Greenock, PA16 0XN
Diana Princess of Wales Hosp.
Grimsby, DN33 2BA
Royal Surrey County Hospital
Guildford, GU2 7XX
Princess Alexandra Hospital; Oncology Department
Harlow, CM20 1QX
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA
Ipswich Hospital
Ipswich, IP4 5PD
Crosshouse Hospital; Dept of Oncology
Kilmarnock, KA2 0BE
Forth Valley Royal Hospital ; Oncology Department
Larbert, FK5 4QE
Leicester Royal Infirmary
Leicester, LE1 5WW
St John's Hospital
Livingston, EH54 6PP
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
Queen Elizabeth Hospital
London, SE18 4QH
St George's Hospital
London, SW17 0QT
Macclesfield District General Hospital
Macclesfield, SK10 3BL
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne, NE7 7DN
Royal Gwent Hospital
Newport, NP20 2UB
North Tyneside General Hospital
North Shields, NE29 8NH
Northampton General Hospital NHS Trust
Northampton, NN1 5BD
Derriford Hospital; Plymouth Oncology Centre
Plymouth, PL6 8DH
Poole General Hospital
Poole, BH15 2JB
Queen Alexandra Hospital, Portsmouth
Portsmouth, PO6 3LY
Royal Preston Hospital
Preston, PR2 9HT
Queens Hospital; R&D
Romford, RM7 0AE
Scarborough General Hospital
Scarborough, YO12 6QL
Royal Shrewsbury Hospital; Pharmacy Department
Shrewsbury, SY3 8XQ
Southampton General Hospital
Southampton, SO16 6YD
Sunderland Royal Hospital
Sunderland, SR4 7TP
Singleton Hospital; Pharmacy Department
Swansea, SA2 8QA
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, SN3 6BB
Royal Cornwall Hospital
Truro, TR1 3LQ
Royal Hampshire County Hospital; Winchester & Andover Breast Unit
Winchester, SO22 5DG
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP
Airedale General Hospital; Oncology
York, BD20 6TD
York District Hospital
York, YO31 8HE
France45 sites
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030
Clinique Tivoli; Sce Radiotherapie
Bordeaux, 33000
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077
Ch De Fleyriat; Pneumologie 1
Bourg-en-Bresse, 01012
Hopital Augustin Morvan; Federation De Cancerologie
Brest, 29200
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive-la-Gaillarde, 19312
Clinique Sainte Marie; Chimiotherapie
Chalon-sur-Saône, 71100
Fondation Clement Drevon; Oncology
Dijon, 21000
Centre Georges-François Lecler; Ctr de Lutte Contre le Canc
Dijon, 21034
Ch De La Dracenie; Hopital De Jour
Draguignan, 83007
Hopital Prive Drome Ardeche; Chir 2A 2B
Guilherand-Granges, 07500
Clinique Sainte Marguerite; Oncologie Medicale
Hyères, 83400
CHD Les Oudairies
La Roche-sur-Yon, 85925
Hopital Albert Michallon; Oncologie
La Tronche, 38700
Ch Du Mans; Medecine Hematologie Oncologie
Le Mans, 72037
Clinique Victor Hugo
LeMans, 72000
Centre Hartmann
Levallois-Perret, 92300
Polyclinique Du Bois; Centre Bourgogne
Lille, 59000
Hopital Claude Huriez; Medecine Interne Oncologie
Lille, 59037
Ch Bretagne Sud Site Scorff; Oncologie Medicale
Lorient, 56100
CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie
Lorient, 56322
Ctre Consultations La Sauvegarde
Lyon, 69338
Hôpital Saint Joseph; Oncologie Medicale
Marseille, 13285
Hopital Clinique Claude Bernard; Oncologie Medicale
Metz, 57000
CHRA;Hematologie
Metz-Tessy, 74370
Clinique Clementville; Hopital De Jour
Montpellier, 34070
Centre Azureen De Cancerologie; Cons externes
Mougins, 06250
Centre Antoine Lacassagne; B3 Medecine Conventionnelle
Nice, 06189
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, 75014
Hopital Hotel Dieu; Oncologie Medicale
Paris, 75181
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Ch Francois Mitterrand; Medecine Oncologie
Pau, 64046
Ch Lyon Sud; Onco Secteur Jules Courmont
Pierre-Bénite, 69495
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, 35768
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805
Clinique de L'Union; Oncologie
Saint-Jean, 31240
CMCO De La Cote D Opale; Auberge De Jour
Saint-Martin-Boulogne, 62280
Institut de Cancerologie de La Loire; Pneumologie
Saint-Priest-en-Jarez, 42270
Ch De Saint Quentin; Medecine B10
Saint-Quentin, 02321
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065
Hopitaux Du Leman Site Thonon; Maternite Gynecologie
Thonon-les-Bains, 74203
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
Clinique Pasteur; Pneumologie
Toulouse, 31076
Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie
Valenciennes, 59326
Centre-Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Spain33 sites
Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia
Albacete, 02006
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, 3010
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, 08916
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041
Hospital Duran i Reynals; Oncologia
Barcelona, 08907
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, 48013
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, 09006
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, 10003
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital General de Elda; Servicio de Oncologia
Elda, Alicante, 03600
Hospital de Cabueñes; Servicio de Oncologia
Gijón, Principality of Asturias, 33394
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35016
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35020
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, 24071
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, 25198
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, 31008
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014
Hospital Quiron de Madrid; Servicio de Oncologia
Pozuelo de Alarcón, Madrid, 28223
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208
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 Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015
Hospital Do Meixoeiro; Servicio de Oncologia
Vigo, Pontevedra, 36214
Hospital Lluis Alcanys; Servicio de Oncologia
Xàtiva, Valencia, 46800
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza, 50009
Italy31 sites
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24127
Ospedale Oncologico A.Businco; Div. Oncologia Medica II
Cagliari, Sardinia, 09121
Ospedale Civile; Oncologia Medica
Camposampiero, Veneto, 35012
Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare
Catania, Sicily, 95100
Arcispedale S.Anna; Oncologia Medica
Cona (Ferrara), Veneto, 44124
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardy, 26100
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Florence, Tuscany, 50139
Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia
Frosinone, Lazio, 03100
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2
Milan, Lombardy, 20133
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900
Azienda Ospedaliera A. Cardarelli
Naples, Campania, 80131
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Naples, Campania, 80131
Università degli Studi Federico II; Clinica di Oncologia Medica
Naples, Campania, 80131
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, 43100
IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia
Pavia, Lombardy, 27100
Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
Piacenza, Emilia-Romagna, 29100
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Tuscany, 56100
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
Pontedera, Tuscany, 56025
Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
Ravenna, Emilia-Romagna, 48100
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
Rionero in Vulture, Basilicate, 85028
IFO - Istituto Regina Elena; Oncologia Medica
Rome, Lazio, 00144
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, 00161
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, 00189
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano, Lombardy, 20089
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, 71013
Ospedale Civile SS Annunziata; oncologia medica
Sassari, Sardinia, 07100
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Turin, Piedmont, 10126
Ospedale Belcolle Di Viterbo; Oncologia
Viterbo, Lazio, 01100
Netherlands20 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
Onze Lieve Vrouwe Gasthuis
AC Amsterdam, 1091
Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde
Apeldoorn, 7334 DZ
Rijnstate Ziekenhuis; Inwendige Geneeskunde
Arnhem, 6815 AD
Albert Schweitzer Ziekenhuis - loc Dordrecht
Dordrecht, 3318 AT
Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde
Ede, 6716 RP
Catharina Ziekenhuis; Dept of Internal Medicin
Eindhoven, 5623 EJ
Maxima Medisch Centrum; Inwendige Geneeskunde
Eindhoven, 5631 BM
Martini Ziekenhuis; Dept of Internal Medicine
Groningen, 9728 NT
Atrium Medisch Centrum Parkstad, Heerlen
Heerlen, 6419 PC
Spaarne Ziekenhuis; Inwendige Geneeskunde
Hoofddorp, 2134 TM
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM
Franciscus Ziekenhuis
Roosendaal, 4708 AE
Maasstad ziekenhuis; Afdeling oncologie hematologie
Rotterdam, 3079 DZ
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde
Schiedam, 3100 AE
Zuyderland ziekenhuis locatie Geleen
Sittard-Geleen, 6162 BG
Diakonessenhuis Utrecht: ziekenhuisapotheek
Utrecht, 3582 KE
Ziekenhuis VieCurie Vitaal
Venlo, 5912 BL
Zaans Medisch Centrum
Zaandam, 1502 DV
Turkey (Türkiye)10 sites
Ankara Uni School of Medicine; Medical Oncology
Ankara, 06590
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, 07070
Dicle University Faculty of Medicine
Diyarbakır, 21280
Gaziantep Univ. Med. Fac.
Gaziantep, 27310
Istanbul Uni of Medicine Faculty; Oncology Dept
Istanbul, 34390
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, 34890
Kocaeli University Faculty of Medicine; Medical oncology
İzmit, 31380
Mersin University Medical Faculty
Mersin, 33169
19 Mayis University Medical Faculty; Medical Oncology Department
Samsun, 55139
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230
Australia9 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Western Hospital
Footscray, Victoria, 3011
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
St George Hospital; Cancer Care Centre
Kogarah, New South Wales, 2217
Cabrini Medical Centre; Oncology
Malvern, Victoria, 3144
Royal Perth Hospital; Department of Medical Oncology
Perth, Western Australia, 6000
Prince of Wales Hospital; Oncology
Randwick, New South Wales, 2031
Queen Elizabeth Hospital; Medical Oncology
Woodville South, South Australia, 5011
Princess Alexandra Hospital; Division of Cancer Services
Woolloongabba, Queensland, 4102
Greece9 sites
Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth
Alexandroupoli, 681 00
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, 115 22
Laiko General Hospital; 1St Pathological Clinic
Athens, 115 27
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28
Periph. University General Hospital of Heraklion Crete; Oncology Department
Heraklion, 711 10
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64
University Hospital of Larissa; Oncology
Larissa, 413 35
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546450
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29
Romania9 sites
Policlinica Sfanta Maria - Oncology; Medical Oncology
Baia Mare, 430241
Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
Bucharest, 022328
Emergency University Bucharest Hospital; Oncology Department
Bucharest, 050098
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, 400006
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015
SC Oncolab SRL
Craiova, 200385
Clinical Hospital 1 Craiova; Medical Oncology
Craiova, 200642
S.C. Life Search S.R.L; Medical Oncology Clinic
Timișoara, 300167
ONCOMED - Medical Centre
Timișoara, 300239
Switzerland9 sites
Hirslanden Medical Center, Tumorzentrum
Aarau, 5000
Kantonsspital Baden; Frauenklinik
Baden, 5405
Ospedale San Giovanni; Oncologia
Bellinzona, 6500
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, 3010
Kantonsspital Frauenfeld, Frauenklinik Thurgau
Frauenfeld, 8501
CHUV; Departement d'Oncologie
Lausanne, 1011
Spital Thun; Medizinische Klinik
Thun, 3600
Kantonsspital Winterthur; Medizinische Onkologie
Winterthur, 8401
Stadtspital Triemli; Frauenklinik
Zurich, 8063
Canada8 sites
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2
CSSS champlain - Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Hungary8 sites
Szent Margit Hospital; Dept. of Oncology
Budapest, 1032
Szent Imre Hospital; Dept. of Oncology
Budapest, 1115
Orszagos Onkologiai Intezet
Budapest, 1122
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, 4032
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs, 7623
Markusovszky Hospital
Szombathely, 9700
Mexico7 sites
Centro Estatal de Oncología de Campeche
Campeche, 24096
Centro Estatal de Cancerología
Chihuahua City, 31000
Instituto Nacional de Cancerologia; Oncology
Distrito Federal, 14080
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, 03100
Oaxaca Site Management Organization
Oaxaca City, 68000
Cancerologia de Queretaro; Oncologia
Queretaro, Queretaro, 76090
Centro Estatal de Cancerologia de Nayarit
Tepic, 63170
Poland7 sites
Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki
Krakow, 30-688
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, 05-400
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu
Poznan, 60-569
Wielkopolskie Centrum Onkologi
Poznan, 61-866
MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie
Rzeszów, 35-021
Wojewodzki Szpital Zespolony
Torun, 87-100
NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna
Żory, 44-240
Russia7 sites
Regional Oncology Hospital
Irkutsk, 664035
City Oncological Hospital
Izhevsk, 426009
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, 115478
City Clinical Oncology Hospital
Moscow, 143423
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, 460021
City Clinical Oncology Dispensary, SPb SBIH CCOD
Saint Petersburg, 198255
Bashkirian Republican Clinical Oncology Dispensary
Ufa, 450054
Brazil6 sites
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
Centro de Oncologia da Bahia - CENOB
Salvador, Estado de Bahia, 41820-021
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Ireland6 sites
Mater Misericordiae Uni Hospital; Oncology
Dublin, 7
Mater Private Hospital
Dublin, 7
Beaumont Hospital; Cancer Clinical Trials Unit
Dublin, 9
University Hospital Limerick
Limerick
Sligo General Hospital; Oncology
Sligo
Waterford Regional Hospital; Department Of Medical Oncology
Waterford
Thailand6 sites
Department of Surgery, King Chulalongkorn Memorial Hospital
Bangkok, 10330
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok, 10400
Rajvithi Hospital
Bangkok, 10400
Ramathibodi Hospital; Medicine/Oncology
Bangkok, 10400
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, 50200
Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine
Dusit, 10300
Indonesia5 sites
Hasan Sadikin Hospital; Internal Medicine
Bandung, 40161
CiptoMangunkusumo Hospital; Internal Medicine
Central Jakarta, 10430
Soetomo Hospital; Surgery
East Java, 60286
Dharmais National Cancer Center
Jakarta, 11420
Sardjito Hospital; Instalasi Kanker Tulip
Yogyakarta, 55284
Peru5 sites
Centro Medico Monte Carmelo
Arequipa, 04001
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34
Clinica de Especialidades Medicas
Lima, Lima 41
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41
Instituto Oncologico de Lima
Lima, Lima27
Serbia5 sites
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, 11000
Institute for Onc/Rad Serbia
Belgrade, 11000
Oncology Institute of Vojvodina
Kamenitz, 21204
Clinical Center Kragujevac
Kragujevac, 34000
Clinical Centre Nis, Clinic for Oncology
Niš, 18000
Slovakia5 sites
Mammacentrum sv. Agáty
Banská Bystrica, 974 01
National Cancer Institute - Comenius University; Dept. Clinical Oncology
Bratislava, 811 05
Vychodoslovensky onkologicky ustav
Košice, 040 01
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
Prešov, 081 81
Fakultna nemocnica Trencín; Onkologicke odd.
Trenčín, 911 71
South Korea5 sites
National Cancer Center
Goyang-si, 10408
Samsung Medical Center
Seoul, (0)6351
Korea University Guro Hospital
Seoul, 08308
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752
Asan Medical Center.
Seoul, 138-736
Chile4 sites
Centro Oncológico Antofagasta
Antofagasta, 1240000
Instituto Nacional del Cancer
Santiago, 8380000
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, 4800827
Hospital Carlos Van Buren, Servicio de Oncologia
Valparaíso, 2341391
Malaysia4 sites
Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi
George Town, 10990
University Malaya Medical Centre; Clinical Oncology Unit,
Kuala Lumpur, 59100
Hospital Wanita dan Kanak-Kanak Sabah
Sabah, Sabah, 88996
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
Sarawak, Sarawak, 93586
Pakistan4 sites
Shifa International Hospital; Department of Oncology
Islamabad, 44000
Aga Khan University; Department of Oncology
Karachi, 74800
Shaukat Khanum Memorial Cancer Hospital; Department of Oncology
Lahore, 54000
Hameed Latif Hospital; Department of Oncology
Lahore, 54600
Portugal4 sites
Centro Clinico Champalimaud; Oncologia Medica
Lisbon, 1400-038
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, 1500-650
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072
Hospital de Sao Joao; Servico de Oncologia
Porto, 4200-319
Taiwan4 sites
China Medical University Hospital; Surgery
Taichung, 404
National Cheng Kung Uni Hospital; Surgery
Tainan, 704
National Taiwan Uni Hospital; General Surgery
Taipei, 100
Tri-Service General Hospital, Division of General Surgery
Taipei, 114
Argentina3 sites
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD
Hospital Britanico; Oncologia
Buenos Aires, C1280AEB
Instituto De Investigaciones Clinicas Zarate
Zárate, 2800
Bulgaria3 sites
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
Plovdiv, 4004
MHAT Serdika; Department of medical oncology
Sofia, 1303
SHATOD - Sofia
Sofia, 1784
Czechia3 sites
Masarykův onkologický ústav; Klinika komplexní onkologické péče
Brno, 656 53
Fakultní nemocnice Olomouc
Olomouc, 775 20
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Prague, 150 06
Ecuador3 sites
Instituto de Cáncer SOLCA Cuenca; Oncología
Cuenca, EC010107
Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology
Guayaquil, EC090112
Hospital Solca Quito; Oncologia
Quito, EC170124
Egypt3 sites
Alexandria Uni ; Medical Oncology
Alexandria, 11737
Manial Specialized Hospital; Oncology
Cairo, 11555
Nci; Oncology Dept
Cairo, 11796
Norway3 sites
Sørlandet Sykehus Kristiansand
Kristiansand, 4604
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Oslo, 0450
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
Stavanger, 4011
South Africa3 sites
Westridge Medical Center
Durban, 4058
Donald Gordon Medical Centre
Johannesburg, 2193
Steve Biko Academic Hospital; Oncology
Pretoria, 0002
Uruguay3 sites
Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología
Montevideo, 11400
Hospital Militar; Oncologia
Montevideo, 11600
Hospital Pereira Rossell; Oncology Department
Montevideo, 11600
Venezuela3 sites
Instituto Oncológico Luis Razetti
Caracas, 1010
Centro Integral de Oncología
Caracas, 1060
Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos
Caracas, 1080
Bosnia and Herzegovina2 sites
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 7100
Colombia2 sites
Clinica del Country
Bogotá, 11001
Clínica Imbanaco; Oncology
Cali
Croatia2 sites
Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
Osijek, 31000
Clinical Hospital Centre Zagreb
Zagreb, 10000
Guatemala2 sites
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01010
Grupo Angeles
Guatemala City, 01015
Hong Kong2 sites
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin
Lithuania2 sites
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, 50009
Klaipeda University Hospital
Klaipėda, 92288
Philippines2 sites
Philippine General Hospital; Section Of Medical Oncology
Manila, 1000
East Avenue Medical Center
Quezon City, 1100
Saudi Arabia2 sites
King Faisal Specialist Hospital & Research Centre
Jeddah, 21499
King Abdul Aziz Medical City, King Fahd National Guard; Oncology
Riyadh, 22490
Sweden2 sites
Skånes University Hospital, Skånes Department of Onclology
Lund, 221 85
Skaraborgs sjukhus Skoevde, Dept of surgery
Skövde, 54185
Ukraine2 sites
Kyiv City Clinical Oncological Center; Chemotherapy Department
Kiev, 03115
State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
Lviv, 79031
Albania1 site
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000
Dominican Republic1 site
Hospital Metropolitano de Santiago
Santiago de los Caballeros, 51000
New Zealand1 site
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga, 3112
Slovenia1 site
University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology
Maribor, 2000
About this study
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
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC 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 participants (Cohort B).
- Conditions
- Breast Neoplasms
- Being tested
- Herceptin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerceptinDrug
Also called Trastuzumab
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: SC Herceptin by Needle/Syringe | Experimental | Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation. Receives: Drug: Herceptin |
| Cohort B: SC Herceptin by SID | Experimental | Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant. Receives: Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
Measured: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
Measured: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With Treatment Interruption Due to an AE
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
Measured: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Number of Herceptin Cycles Received
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Measured: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants by Total Number of Herceptin Cycles Received
Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
Measured: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants Who Received Concomitant Cancer Therapy
Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
Measured: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
Measured: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Secondary outcomes (5)
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
The percentage of participants who died from any cause was reported.
Measured: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Percentage of Participants Who Died During the Safety Follow-up Period
The percentage of participants who died from any cause was reported during the safety follow-up period.
Measured: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Disease-Free Survival Rate
DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.
Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Measured: From Baseline to time of event (up to approximately 8 years)
Overall Survival Rate
Overall survival was defined as the time from randomization to death from any cause.
Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Measured: From Baseline to Time of Event (Up to Approximately 6 Years)
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
Measured: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study start17 May 2012
- Primary completion10 Mar 2015
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566721
- Sponsor's protocol ID
- MO28048
- Other IDs
- 2011-005328-17
- Acronym
- SafeHER
- Status last verified
- Apr 2021
- First submitted
- 22 Mar 2012
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Jung KH, Ataseven B, Verrill M, Pivot X, De Laurentiis M, Al-Sakaff N, Lauer S, Shing M, Gligorov J, Azim HA. Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study. Oncologist. 2018 Oct;23(10):1137-1143. doi: 10.1634/theoncologist.2018-0065. Epub 2018 Jul 17.
PubMed 30018134Gligorov J, Ataseven B, Verrill M, De Laurentiis M, Jung KH, Azim HA, Al-Sakaff N, Lauer S, Shing M, Pivot X; SafeHer Study Group. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.
PubMed 28625777