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

Breast Neoplasms Clinical Trial

— SafeHER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566721
• Other study ID #: MO28048
• Secondary ID: 2011-005328-17
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2012
• Est. completion date: February 19, 2020

Study information

• Verified date: April 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2577
• Est. completion date: February 19, 2020
• Est. primary completion date: March 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%

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, 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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Herceptin
Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.

Locations

Country	Name	City	State
Albania	University "Mother Theresa" Hospital Center; Oncology Department	Tirana
Algeria	CPMC; Service d'Oncologie Médicale	Algiers
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Hospital Britanico; Oncologia	Buenos Aires
Argentina	Instituto De Investigaciones Clinicas Zarate	Zarate
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Western Hospital	Footscray	Victoria
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	St George Hospital; Cancer Care Centre	Kogarah	New South Wales
Australia	Cabrini Medical Centre; Oncology	Malvern	Victoria
Australia	Royal Perth Hospital; Department of Medical Oncology	Perth	Western Australia
Australia	Prince of Wales Hospital; Oncology	Randwick	New South Wales
Australia	Queen Elizabeth Hospital; Medical Oncology	Woodville South	South Australia
Australia	Princess Alexandra Hospital; Division of Cancer Services	Woolloongabba	Queensland
Bosnia and Herzegovina	University Clinical Center of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	Clinic of Oncology, University Clinical Center Sarajevo	Sarajevo
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Centro de Oncologia da Bahia - CENOB	Salvador	BA
Brazil	Hospital Sao Rafael - HSR	Salvador	BA
Brazil	Hospital Perola Byington	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Bulgaria	Complex Oncology Center - Plovdiv First Internal Chemotherapy Department	Plovdiv
Bulgaria	MHAT Serdika; Department of medical oncology	Sofia
Bulgaria	SHATOD - Sofia	Sofia
Canada	Cross Cancer Institute ; Dept of Medical Oncology	Edmonton	Alberta
Canada	CSSS champlain - Charles-Le Moyne	Greenfield Park	Quebec
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Mcgill University - Royal Victoria Hospital; Oncology	Montreal	Quebec
Canada	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario
Canada	St. Michael'S Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Chile	Centro Oncológico Antofagasta	Antofagasta
Chile	Instituto Nacional del Cancer	Santiago
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Chile	Hospital Carlos Van Buren, Servicio de Oncologia	Valparaiso
Colombia	Clinica del Country	Bogota
Colombia	Clínica Imbanaco; Oncology	Cali
Croatia	Clinical Hospital Osijek; Dept For Oncology & Radiotherapy	Osijek
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Czechia	Masarykuv onkologický ústav; Klinika komplexní onkologické péce	Brno
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni	Praha 5
Dominican Republic	Hospital Metropolitano de Santiago	Santiago
Ecuador	Instituto de Cáncer SOLCA Cuenca; Oncología	Cuenca
Ecuador	Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology	Guayaquil
Ecuador	Hospital Solca Quito; Oncologia	Quito
Egypt	Alexandria Uni ; Medical Oncology	Alexandria
Egypt	Manial Specialized Hospital; Oncology	Cairo
Egypt	Nci; Oncology Dept	Cairo
El Salvador	Hospital Oncologia; Oncology	Salvador
France	HOPITAL JEAN MINJOZ; Oncologie	Besancon
France	Clinique Tivoli; Sce Radiotherapie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie	Bordeaux
France	Ch De Fleyriat; Pneumologie 1	Bourg En Bresse
France	Hopital Augustin Morvan; Federation De Cancerologie	Brest
France	Ch De Brive La Gaillarde; Radiotherapie Oncologie	Brive La Gaillarde
France	Clinique Sainte Marie; Chimiotherapie	Chalon Sur Saone
France	Centre Georges-François Lecler; Ctr de Lutte Contre le Canc	Dijon
France	Fondation Clement Drevon; Oncology	Dijon
France	Ch De La Dracenie; Hopital De Jour	Draguignan
France	Hopital Prive Drome Ardeche; Chir 2A 2B	Guilherand Granges
France	Clinique Sainte Marguerite; Oncologie Medicale	Hyeres
France	CHD Les Oudairies	La Roche Sur Yon
France	Hopital Albert Michallon; Oncologie	La Tronche
France	Ch Du Mans; Medecine Hematologie Oncologie	Le Mans
France	Clinique Victor Hugo	LeMans
France	Centre Hartmann	Levallois Perret
France	Hopital Claude Huriez; Medecine Interne Oncologie	Lille
France	Polyclinique Du Bois; Centre Bourgogne	Lille
France	CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie	Lorient
France	Ch Bretagne Sud Site Scorff; Oncologie Medicale	Lorient
France	Ctre Consultations La Sauvegarde	Lyon
France	Hôpital Saint Joseph; Oncologie Medicale	Marseille
France	Hopital Clinique Claude Bernard; Oncologie Medicale	Metz
France	CHRA;Hematologie	Metz Tessy
France	Clinique Clementville; Hopital De Jour	Montpellier
France	Centre Azureen De Cancerologie; Cons externes	Mougins
France	Centre Antoine Lacassagne; B3 Medecine Conventionnelle	Nice
France	Hopital Cochin; Unite Fonctionnelle D Oncologie	Paris
France	Hopital Hotel Dieu; Oncologie Medicale	Paris
France	HOPITAL TENON; Cancerologie Medicale	Paris
France	Ch Francois Mitterrand; Medecine Oncologie	Pau
France	Ch Lyon Sud; Onco Secteur Jules Courmont	Pierre Benite
France	Chp Saint Gregoire; Cancerologie Radiotherapie	Saint Gregoire
France	Ico Rene Gauducheau; Oncologie	Saint Herblain
France	Clinique de L'Union; Oncologie	Saint Jean
France	Ch De Saint Quentin; Medecine B10	Saint Quentin
France	Institut de Cancerologie de La Loire; Pneumologie	Saint-priest-en-jarez
France	CMCO De La Cote D Opale; Auberge De Jour	St Martin Boulogne
France	Centre Paul Strauss; Oncologie Medicale	Strasbourg
France	Hopitaux Du Leman Site Thonon; Maternite Gynecologie	Thonon Les Bains
France	Clinique Pasteur; Pneumologie	Toulouse
France	Institut Claudius Regaud; Departement Oncologie Medicale	Toulouse
France	Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie	Valenciennes
France	Centre-Alexis Vautrin	Vandoeuvre-les-Nancy
Germany	Klinikum Augsburg; Frauenklinik	Augsburg
Germany	Internist; Praxis Für Haemotologie & Onkologie	Bad Soden
Germany	Praxis Dres. Schilling & Till	Berlin
Germany	Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen	Berlin
Germany	Katholische Hospitalvereinigung Ostwestfalen gGmbH	Bielefeld
Germany	Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel	Bochum
Germany	DONAU ISAR Klinikum Deggendorf; Frauenklinik	Deggendorf
Germany	Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum	Essen
Germany	Universitätsklinikum Essen; Zentrum Für Frauenheilkunde	Essen
Germany	Universitätsklinikum Freiburg; Frauenklinik	Freiburg
Germany	Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe	Georgsmarienhütte
Germany	Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe	Halle
Germany	Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie	Hamburg
Germany	Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding	Hannover
Germany	Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe	Hannover
Germany	Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin	Jena
Germany	Elisabeth-Krankenhaus Brustzentrum	Kassel
Germany	St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe	Koeln
Germany	Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum	Köln
Germany	Praxis Dr.med. Katja Ziegler-Löhr	Köln
Germany	Klinikum Kulmbach; Frauenklinik	Kulmbach
Germany	Dres. Andreas Köhler und Roswitha Fuchs	Langen
Germany	Klinikum Leverkusen; Med. Klinik III / Onkologie	Leverkusen
Germany	Onkologische Schwerpunktpraxis Lübeck	Lübeck
Germany	Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe	Lübeck
Germany	Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe	Ludwigsburg
Germany	Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde	Mainz
Germany	Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach	Marburg
Germany	Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe	Meiningen
Germany	Klinikum Memmingen; Abt.Gynäkologie	Memmingen
Germany	Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe	Minden
Germany	Praxis Dr.med. Steffi Busch	Mühlhausen
Germany	Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer	München
Germany	Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik	München
Germany	Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe	Münster
Germany	Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe	Neuruppin
Germany	Klinikum Nord Frauenklinik	Nürnberg
Germany	Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe	Offenbach
Germany	medius KLINIK OSTFILDERN-RUIT; Brustzentrum	Ostfildern
Germany	Oncologianova GmbH	Recklinghausen
Germany	Agaplesion Diakonieklinikum Rotenburg	Rotenburg/Wümme
Germany	Caritas Klinik St. Theresia -Frauenklinik Brustzentrum	Saarbruecken
Germany	Leopoldina Krankenhaus der Stadt Schweinfurt GmbH	Schweinfurt
Germany	HELIOS Klinikum Schwerin; Frauenklinik	Schwerin
Germany	Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe	Stendal
Germany	Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe	Torgau
Germany	Universitätsklinik Tübingen; Frauenklinik	Tübingen
Germany	Katharinen-Hospital gGmbH	Unna
Germany	GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe	Weinheim
Germany	ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH	Weißenfels
Germany	Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe	Wetzlar
Germany	Gesellschaft für Medizinische Studien Würselen	Wuerselen
Greece	Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth	??e?a?d???p???
Greece	University Hospital of Larissa; Oncology	?a??sa
Greece	Alexandras General Hospital of Athens; Oncology Department	Athens
Greece	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens
Greece	Laiko General Hospital; 1St Pathological Clinic	Athens
Greece	Periph. University General Hospital of Heraklion Crete; Oncology Department	Heraklion
Greece	Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.	Kifisia
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Greece	Papageorgiou General Hospital; Medical Oncology	Thessaloniki
Guatemala	Centro Oncológico Sixtino / Centro Oncológico SA	Guatemala
Guatemala	Grupo Angeles	Guatemala City
Hong Kong	Queen Elizabeth Hospital; Clinical Oncology	Hong Kong
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika	Budapest
Hungary	Szent Imre Hospital; Dept. of Oncology	Budapest
Hungary	Szent Margit Hospital; Dept. of Oncology	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont ; Department of Oncology	Debrecen
Hungary	Josa Andras Korhaz; Dept of Oncoradiology	Nyíregyháza
Hungary	Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet	Pécs
Hungary	Markusovszky Hospital	Szombathely
Indonesia	Hasan Sadikin Hospital; Internal Medicine	Bandung
Indonesia	CiptoMangunkusumo Hospital; Internal Medicine	Central Jakarta
Indonesia	Soetomo Hospital; Surgery	East Java
Indonesia	Dharmais National Cancer Center	Jakarta
Indonesia	Sardjito Hospital; Instalasi Kanker Tulip	Jogjakarta
Ireland	Beaumont Hospital; Cancer Clinical Trials Unit	Dublin
Ireland	Mater Misericordiae Uni Hospital; Oncology	Dublin
Ireland	Mater Private Hospital	Dublin
Ireland	University Hospital Limerick	Limerick City
Ireland	Sligo General Hospital; Oncology	Sligo
Ireland	Waterford Regional Hospital; Department Of Medical Oncology	Waterford
Italy	Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica	Bari	Puglia
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	Ospedale Oncologico A.Businco; Div. Oncologia Medica II	Cagliari	Sardegna
Italy	Ospedale Civile; Oncologia Medica	Camposampiero	Veneto
Italy	Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare	Catania	Sicilia
Italy	Arcispedale S.Anna; Oncologia Medica	Cona (Ferrara)	Veneto
Italy	ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit	Cremona	Lombardia
Italy	Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1	Firenze	Toscana
Italy	Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia	Frosinone	Lazio
Italy	Ospedale Vito Fazzi; Div. Oncoematologia	Lecce	Puglia
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2	Milano	Lombardia
Italy	ASST DI MONZA; Oncologia Medica	Monza	Lombardia
Italy	Azienda Ospedaliera A. Cardarelli	Napoli	Campania
Italy	Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica	Napoli	Campania
Italy	Università degli Studi Federico II; Clinica di Oncologia Medica	Napoli	Campania
Italy	Ospedale Regionale Di Parma; Divisione Di Oncologia Medica	Parma	Emilia-Romagna
Italy	IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia	Pavia	Lombardia
Italy	Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia	Piacenza	Emilia-Romagna
Italy	Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2	Pisa	Toscana
Italy	Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia	Pontedera	Toscana
Italy	Azienda USL di Ravenna; Unità Operativa di Oncologia Medica	Ravenna	Emilia-Romagna
Italy	Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia	Rionero in Vulture	Basilicata
Italy	Azienda Ospedaliera Sant'Andrea	Roma	Lazio
Italy	IFO - Istituto Regina Elena; Oncologia Medica	Roma	Lazio
Italy	Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche	Roma	Lazio
Italy	IRCCS Istituto Clinico Humanitas; Oncologia	Rozzano	Lombardia
Italy	IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia	San Giovanni Rotondo	Puglia
Italy	Ospedale Civile SS Annunziata; oncologia medica	Sassari	Sardegna
Italy	A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica	Torino	Piemonte
Italy	Ospedale Belcolle Di Viterbo; Oncologia	Viterbo	Lazio
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center.	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Yonsei University Severance Hospital; Medical Oncology	Seoul
Lithuania	Hospital of Lithuanian University of Health. Sciences Kaunas Clinics	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Malaysia	Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi	Georgetown
Malaysia	University Malaya Medical Centre; Clinical Oncology Unit,	Kuala Lumpur
Malaysia	Hospital Wanita dan Kanak-Kanak Sabah	Sabah
Malaysia	Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care	Sarawak
Mexico	Centro Estatal de Oncología de Campeche	Campeche
Mexico	Centro Estatal de Cancerología	Chihuahua
Mexico	Instituto Nacional de Cancerologia; Oncology	Distrito Federal
Mexico	Consultorio de Medicina Especializada; Dentro de Condominio San Francisco	Mexico City
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Cancerologia de Queretaro; Oncologia	Queretaro, Queretaro
Mexico	Centro Estatal de Cancerologia de Nayarit	Tepic
Morocco	Institut National D'oncologie Sidi Med Benabdellah	Rabat
Netherlands	Jeroen Bosch Ziekenhuis	'S Hertogenbosch
Netherlands	Onze Lieve Vrouwe Gasthuis	AC Amsterdam
Netherlands	Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde	Apeldoorn
Netherlands	Rijnstate Ziekenhuis; Inwendige Geneeskunde	Arnhem
Netherlands	Albert Schweitzer Ziekenhuis - loc Dordrecht	Dordrecht
Netherlands	Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde	EDE
Netherlands	Catharina Ziekenhuis; Dept of Internal Medicin	Eindhoven
Netherlands	Maxima Medisch Centrum; Inwendige Geneeskunde	Eindhoven
Netherlands	Martini Ziekenhuis; Dept of Internal Medicine	Groningen
Netherlands	Atrium Medisch Centrum Parkstad, Heerlen	Heerlen
Netherlands	Spaarne Ziekenhuis; Inwendige Geneeskunde	Hoofddorp
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Franciscus Ziekenhuis	Roosendaal
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Maasstad ziekenhuis; Afdeling oncologie hematologie	Rotterdam
Netherlands	Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde	Schiedam
Netherlands	Zuyderland ziekenhuis locatie Geleen	Sittard-Geleen
Netherlands	Diakonessenhuis Utrecht: ziekenhuisapotheek	Utrecht
Netherlands	Ziekenhuis VieCurie Vitaal	Venlo
Netherlands	Zaans Medisch Centrum	Zaandam
New Zealand	Tauranga Hospital, Clinical Trials Unit; BOP Clinical School	Tauranga
Norway	Sørlandet Sykehus Kristiansand	Kristiansand
Norway	Oslo universitetssykehus HF, Ullevål, Kreftsenteret	Oslo
Norway	Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer	Stavanger
Pakistan	Shifa International Hospital; Department of Oncology	Islamabad
Pakistan	Aga Khan University; Department of Oncology	Karachi
Pakistan	Hameed Latif Hospital; Department of Oncology	Lahore
Pakistan	Shaukat Khanum Memorial Cancer Hospital; Department of Oncology	Lahore
Panama	Centro Hemato Oncologico Panama	Panama
Peru	Centro Medico Monte Carmelo	Arequipa
Peru	Clinica de Especialidades Medicas	Lima
Peru	Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Instituto Oncologico de Lima	LIma
Philippines	Philippine General Hospital; Section Of Medical Oncology	Manila
Philippines	East Avenue Medical Center	Quezon City
Poland	Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki	Kraków
Poland	Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii	Otwock
Poland	Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu	Poznan
Poland	Wielkopolskie Centrum Onkologi	Poznan
Poland	MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie	Rzeszow
Poland	Wojewodzki Szpital Zespolony	Torun
Poland	NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna	Zory
Portugal	Centro Clinico Champalimaud; Oncologia Medica	Lisboa
Portugal	Hospital da Luz; Departamento de Oncologia Medica	Lisboa
Portugal	Hospital de Sao Joao; Servico de Oncologia	Porto
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Romania	Policlinica Sfanta Maria - Oncology; Medical Oncology	Baia Mare
Romania	Emergency University Bucharest Hospital; Oncology Department	Bucharest
Romania	Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department	Bucuresti
Romania	Prof. Dr. I. Chiricuta Institute of Oncology	Cluj Napoca
Romania	Cluj Clinical County Hospital; Oncology Dept	Cluj-Napoca
Romania	Clinical Hospital 1 Craiova; Medical Oncology	Craiova
Romania	SC Oncolab SRL	Craiova
Romania	ONCOMED - Medical Centre	Timisoara
Romania	S.C. Life Search S.R.L; Medical Oncology Clinic	Timisoara
Russian Federation	Regional Oncology Hospital	Irkutsk
Russian Federation	City Oncological Hospital	Izhevsk
Russian Federation	City Clinical Oncology Hospital	Moscow
Russian Federation	Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy	Moscow
Russian Federation	State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis	Orenburg
Russian Federation	City Clinical Oncology Dispensary, SPb SBIH CCOD	Saint-Petersburg
Russian Federation	Bashkirian Republican Clinical Oncology Dispensary	UFA
Saudi Arabia	King Faisal Specialist Hospital & Research Centre	Jeddah
Saudi Arabia	King Abdul Aziz Medical City, King Fahd National Guard; Oncology	Riyadh
Serbia	Clinical Hospital Center Bezanijska kosa; Clinic for Oncology	Belgrade
Serbia	Institute for Onc/Rad Serbia	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Centre Nis, Clinic for Oncology	Nis
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Singapore	National Cancer Centre; Medical Oncology	Singapore
Slovakia	Mammacentrum sv. Agáty	Banská Bystrica
Slovakia	National Cancer Institute - Comenius University; Dept. Clinical Oncology	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav	Košice
Slovakia	Fakultna nemocnica s poliklinikou J.A. Reimana Presov	Presov
Slovakia	Fakultna nemocnica Trencín; Onkologicke odd.	Trencin
Slovenia	University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology	Maribor
South Africa	Westridge Medical Center	Durban
South Africa	Donald Gordon Medical Centre	Johannesburg
South Africa	Steve Biko Academic Hospital; Oncology	Pretoria
Spain	Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia	Albacete
Spain	Hospital General Univ. de Alicante; Servicio de Oncologia	Alicante
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Hospital Duran i Reynals; Oncologia	Barcelona
Spain	Hospital de Basurto; Servicio de Oncologia	Bilbao	Vizcaya
Spain	Complejo Asistencial Universitario De Burgos; Servicio de Oncologia	Burgos
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
Spain	Hospital General de Elda; Servicio de Oncologia	Elda	Alicante
Spain	Hospital de Cabueñes; Servicio de Oncologia	Gijon	Asturias
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas
Spain	Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas
Spain	Complejo Asistencial Universitario de Leon; Servicio de Oncologia	Leon
Spain	Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia	Lerida
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia	Murcia
Spain	Hospital de Navarra; Servicio de Oncologia	Navarra
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Quiron de Madrid; Servicio de Oncologia	Pozuelo de Alarcon	Madrid
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia	San Sebastian	Guipuzcoa
Spain	Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia	Toledo
Spain	Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia	Valencia
Spain	Hospital Do Meixoeiro; Servicio de Oncologia	Vigo	Pontevedra
Spain	Hospital Lluis Alcanys; Servicio de Oncologia	Xativa	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia	Zaragoza
Sweden	Skånes University Hospital, Skånes Department of Onclology	Lund
Sweden	Skaraborgs sjukhus Skoevde, Dept of surgery	Skoevde
Switzerland	Hirslanden Medical Center, Tumorzentrum	Aarau
Switzerland	Kantonsspital Baden; Frauenklinik	Baden
Switzerland	Ospedale San Giovanni; Oncologia	Bellinzona
Switzerland	Inselspital Bern; Universitätsklinik für medizinische Onkologie	Bern
Switzerland	Kantonsspital Frauenfeld, Frauenklinik Thurgau	Frauenfeld
Switzerland	CHUV; Departement d'Oncologie	Lausanne
Switzerland	Spital Thun; Medizinische Klinik	Thun
Switzerland	Kantonsspital Winterthur; Medizinische Onkologie	Winterthur
Switzerland	Stadtspital Triemli; Frauenklinik	Zürich
Taiwan	China Medical University Hospital; Surgery	Taichung
Taiwan	National Cheng Kung Uni Hospital; Surgery	Tainan
Taiwan	National Taiwan Uni Hospital; General Surgery	Taipei
Taiwan	Tri-Service General Hospital, Division of General Surgery	Taipei
Thailand	Department of Surgery, King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Pramongkutklao Hospital; Medicine - Medical Oncology Unit	Bangkok
Thailand	Rajvithi Hospital	Bangkok
Thailand	Ramathibodi Hospital; Medicine/Oncology	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial	Chiang Mai
Thailand	Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine	Dusit
Turkey	Ankara Uni School of Medicine; Medical Oncology	Ankara
Turkey	Akdeniz University Medical Faculty; Medical Oncology Department	Antalya
Turkey	Dicle University Faculty of Medicine	Diyarbakir
Turkey	Gaziantep Univ. Med. Fac.	Gaziantep
Turkey	Istanbul Uni of Medicine Faculty; Oncology Dept	Istanbul
Turkey	Marmara Uni Faculty of Medicine; Medical Oncology	Istanbul
Turkey	Kocaeli University Faculty of Medicine; Medical oncology	Izmit
Turkey	Mersin University Medical Faculty	Mersin
Turkey	19 Mayis University Medical Faculty; Medical Oncology Department	Samsun
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
Ukraine	Kyiv City Clinical Oncological Center; Chemotherapy Department	Kiev
Ukraine	State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department	Lviv
United Arab Emirates	Tawam Hospital	Al Ain
United Kingdom	Nevill Hall Hospital	Abergavenny
United Kingdom	Bedford Hospital; Oncology	Bedford
United Kingdom	Wexham Park Hospital; Oncology	Berkshire
United Kingdom	Heartlands Hospital; Department Of Medicine	Birmingham
United Kingdom	University Hospital Birmingham Queen Elizabeth Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital; Oncology	Bournemouth
United Kingdom	Kent & Canterbury Hospital	Canterbury
United Kingdom	Broomfield Hospital; Oncology	Chelmsford
United Kingdom	Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr	Denbighshire
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	North Devon District Hospital	Devon
United Kingdom	Russells Hall Hospital; Oncology	Dudley
United Kingdom	University Hospital of North Durham	Durham
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Inverclyde Hospital	Greenock
United Kingdom	Diana Princess of Wales Hosp.	Grimsby
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Princess Alexandra Hospital; Oncology Department	Harlow
United Kingdom	Huddersfield Royal Infirmary	Huddersfield
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Crosshouse Hospital; Dept of Oncology	Kilmarnock
United Kingdom	Forth Valley Royal Hospital ; Oncology Department	Larbert
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	St John's Hospital	Livingston
United Kingdom	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London
United Kingdom	Queen Elizabeth Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Christie Hospital; Breast Cancer Research Office	Manchester
United Kingdom	Freeman Hospital; Northern Centre For Cancer Care	New Castle Upon Tyne
United Kingdom	Royal Gwent Hospital	Newport
United Kingdom	North Tyneside General Hospital	North Shields
United Kingdom	Northampton General Hospital NHS Trust	Northampton
United Kingdom	Derriford Hospital; Plymouth Oncology Centre	Plymouth
United Kingdom	Poole General Hospital	Poole
United Kingdom	Queen Alexandra Hospital, Portsmouth	Portsmouth
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Queens Hospital; R&D	Romford
United Kingdom	Scarborough General Hospital	Scarborough
United Kingdom	Royal Shrewsbury Hospital; Pharmacy Department	Shrewsbury
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Singleton Hospital; Pharmacy Department	Swansea
United Kingdom	Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3	Swindon
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Royal Hampshire County Hospital; Winchester & Andover Breast Unit	Winchester
United Kingdom	The Clatterbridge Cancer Ctr For Oncolgy	Wirral
United Kingdom	The Royal Wolverhampton Hospitals NHS Trust	Wolverhampton
United Kingdom	Airedale General Hospital; Oncology	York
United Kingdom	York District Hospital	York
Uruguay	Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología	Montevideo
Uruguay	Hospital Militar; Oncologia	Montevideo
Uruguay	Hospital Pereira Rossell; Oncology Department	Montevideo
Venezuela	Centro Integral de Oncología	Caracas
Venezuela	Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos	Caracas
Venezuela	Instituto Oncológico Luis Razetti	Caracas
Vietnam	K hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Albania,  Algeria,  Argentina,  Australia,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Dominican Republic,  Ecuador,  Egypt,  El Salvador,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Indonesia,  Ireland,  Italy,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Morocco,  Netherlands,  New Zealand,  Norway,  Pakistan,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Arab Emirates,  United Kingdom,  Uruguay,  Venezuela,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary	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.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary	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.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary	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.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary	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.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Primary	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.	From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Primary	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.	From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
Secondary	Percentage of Participants Who Died by Data Cutoff of 10 March 2015	The percentage of participants who died from any cause was reported.	From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Secondary	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.	From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)
Secondary	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.	From Baseline to time of event (up to approximately 8 years)
Secondary	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.	From Baseline to Time of Event (Up to Approximately 6 Years)
Secondary	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.	Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)