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

NCT ID: NCT01566721

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-17
• Study Completion Date: 2020-02-19

Brief 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).

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: SC Herceptin by Needle/Syringe

Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

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

Cohort B: SC Herceptin by SID

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.

Group Type: EXPERIMENTAL

Herceptin

Intervention Type: DRUG

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

Interventions

Herceptin

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

Intervention Type: DRUG

Other Intervention Names

Trastuzumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University "Mother Theresa" Hospital Center; Oncology Department

Tirana, , Albania

CPMC; Service d'Oncologie Médicale

Algiers, , Algeria

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

Hospital Britanico; Oncologia

Buenos Aires, , Argentina

Instituto De Investigaciones Clinicas Zarate

Zárate, , Argentina

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

St George Hospital; Cancer Care Centre

Kogarah, New South Wales, Australia

Prince of Wales Hospital; Oncology

Randwick, New South Wales, Australia

Princess Alexandra Hospital; Division of Cancer Services

Woolloongabba, Queensland, Australia

Queen Elizabeth Hospital; Medical Oncology

Woodville South, South Australia, Australia

Western Hospital

Footscray, Victoria, Australia

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Cabrini Medical Centre; Oncology

Malvern, Victoria, Australia

Royal Perth Hospital; Department of Medical Oncology

Perth, Western Australia, Australia

University Clinical Center of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, , Bosnia and Herzegovina

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Centro de Oncologia da Bahia - CENOB

Salvador, Estado de Bahia, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Hospital Perola Byington

São Paulo, São Paulo, Brazil

Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

Plovdiv, , Bulgaria

MHAT Serdika; Department of medical oncology

Sofia, , Bulgaria

SHATOD - Sofia

Sofia, , Bulgaria

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, Canada

St. Michael'S Hospital

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CSSS champlain - Charles-Le Moyne

Greenfield Park, Quebec, Canada

Mcgill University - Royal Victoria Hospital; Oncology

Montreal, Quebec, Canada

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

Valparaíso, , Chile

Clinica del Country

Bogotá, , Colombia

Clínica Imbanaco; Oncology

Cali, , Colombia

Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

Osijek, , Croatia

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Masarykův onkologický ústav; Klinika komplexní onkologické péče

Brno, , Czechia

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

Prague, , Czechia

Hospital Metropolitano de Santiago

Santiago de los Caballeros, , Dominican Republic

Instituto de Cáncer SOLCA Cuenca; Oncología

Cuenca, , Ecuador

Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

Guayaquil, , Ecuador

Hospital Solca Quito; Oncologia

Quito, , Ecuador

Alexandria Uni ; Medical Oncology

Alexandria, , Egypt

Manial Specialized Hospital; Oncology

Cairo, , Egypt

Nci; Oncology Dept

Cairo, , Egypt

Hospital Oncologia; Oncology

San Salvador, , El Salvador

HOPITAL JEAN MINJOZ; Oncologie

Besançon, , 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-Saône, , France

Fondation Clement Drevon; Oncology

Dijon, , France

Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

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

Hyères, , 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

Polyclinique Du Bois; Centre Bourgogne

Lille, , France

Hopital Claude Huriez; Medecine Interne Oncologie

Lille, , France

Ch Bretagne Sud Site Scorff; Oncologie Medicale

Lorient, , France

CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

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-Bénite, , France

Chp Saint Gregoire; Cancerologie Radiotherapie

Saint-Grégoire, , France

Ico Rene Gauducheau; Oncologie

Saint-Herblain, , France

Clinique de L'Union; Oncologie

Saint-Jean, , France

CMCO De La Cote D Opale; Auberge De Jour

Saint-Martin-Boulogne, , France

Institut de Cancerologie de La Loire; Pneumologie

Saint-Priest-en-Jarez, , France

Ch De Saint Quentin; Medecine B10

Saint-Quentin, , France

Centre Paul Strauss; Oncologie Medicale

Strasbourg, , France

Hopitaux Du Leman Site Thonon; Maternite Gynecologie

Thonon-les-Bains, , France

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, , France

Clinique Pasteur; Pneumologie

Toulouse, , France

Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie

Valenciennes, , France

Centre-Alexis Vautrin

Vandœuvre-lès-Nancy, , France

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

Praxis Dr.med. Katja Ziegler-Löhr

Cologne, , Germany

St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

Cologne, , Germany

Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

Cologne, , Germany

DONAU ISAR Klinikum Deggendorf; Frauenklinik

Deggendorf, , Germany

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, , Germany

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

Essen, , Germany

Universitätsklinikum Freiburg; Frauenklinik

Freiburg im Breisgau, , 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

Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

Hamburg, , Germany

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, , Germany

Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

Hanover, , Germany

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

Hanover, , 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

Klinikum Kulmbach; Frauenklinik

Kulmbach, , Germany

Dres. Andreas Köhler und Roswitha Fuchs

Langen, , Germany

Klinikum Leverkusen; Med. Klinik III / Onkologie

Leverkusen, , Germany

Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe

Ludwigsburg, , Germany

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

Lübeck, , Germany

Onkologische Schwerpunktpraxis Lübeck

Lübeck, , 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

Nuremberg, , 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

Saarbrücken, , 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

Würselen, , Germany

Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth

Alexandroupoli, , Greece

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, , Greece

Laiko General Hospital; 1St Pathological Clinic

Athens, , Greece

Alexandras General Hospital of Athens; Oncology Department

Athens, , Greece

Periph. University General Hospital of Heraklion Crete; Oncology Department

Heraklion, , Greece

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

Kifissia, , Greece

University Hospital of Larissa; Oncology

Larissa, , Greece

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, , Greece

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, , Greece

Centro Oncológico Sixtino / Centro Oncológico SA

Guatemala City, , Guatemala

Grupo Angeles

Guatemala City, , Guatemala

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, , Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, , Hong Kong

Szent Margit Hospital; Dept. of Oncology

Budapest, , Hungary

Szent Imre Hospital; Dept. of Oncology

Budapest, , Hungary

Orszagos Onkologiai Intezet

Budapest, , Hungary

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

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, , Hungary

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

Yogyakarta, , Indonesia

Mater Misericordiae Uni Hospital; Oncology

Dublin, , Ireland

Mater Private Hospital

Dublin, , Ireland

Beaumont Hospital; Cancer Clinical Trials Unit

Dublin, , Ireland

University Hospital Limerick

Limerick, , Ireland

Sligo General Hospital; Oncology

Sligo, , Ireland

Waterford Regional Hospital; Department Of Medical Oncology

Waterford, , Ireland

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, Italy

Ospedale Vito Fazzi; Div. Oncoematologia

Lecce, Apulia, Italy

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia, Italy

Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

Rionero in Vulture, Basilicate, 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

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, Italy

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

Parma, Emilia-Romagna, Italy

Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

Piacenza, Emilia-Romagna, Italy

Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

Ravenna, Emilia-Romagna, Italy

Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

Frosinone, Lazio, Italy

IFO - Istituto Regina Elena; Oncologia Medica

Rome, Lazio, Italy

Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, Italy

Ospedale Belcolle Di Viterbo; Oncologia

Viterbo, Lazio, Italy

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

Cremona, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2

Milan, Lombardy, Italy

ASST DI MONZA; Oncologia Medica

Monza, Lombardy, Italy

IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia

Pavia, Lombardy, Italy

IRCCS Istituto Clinico Humanitas; Oncologia

Rozzano, Lombardy, Italy

A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

Turin, Piedmont, Italy

Ospedale Oncologico A.Businco; Div. Oncologia Medica II

Cagliari, Sardinia, Italy

Ospedale Civile SS Annunziata; oncologia medica

Sassari, Sardinia, Italy

Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare

Catania, Sicily, Italy

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, Italy

Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

Pisa, Tuscany, Italy

Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

Pontedera, Tuscany, Italy

Ospedale Civile; Oncologia Medica

Camposampiero, Veneto, Italy

Arcispedale S.Anna; Oncologia Medica

Cona (Ferrara), Veneto, Italy

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, , Lithuania

Klaipeda University Hospital

Klaipėda, , Lithuania

Hospital Wanita dan Kanak-Kanak Sabah

Sabah, Sabah, Malaysia

Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

Sarawak, Sarawak, Malaysia

Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi

George Town, , Malaysia

University Malaya Medical Centre; Clinical Oncology Unit,

Kuala Lumpur, , Malaysia

Centro Estatal de Oncología de Campeche

Campeche, , Mexico

Centro Estatal de Cancerología

Chihuahua City, , 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 City, , Mexico

Cancerologia de Queretaro; Oncologia

Queretaro, Queretaro, , Mexico

Centro Estatal de Cancerologia de Nayarit

Tepic, , Mexico

Institut National D'oncologie Sidi Med Benabdellah

Rabat, , Morocco

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

Maasstad ziekenhuis; Afdeling oncologie hematologie

Rotterdam, , Netherlands

Ikazia Ziekenhuis

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, , Netherlands

Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

Tauranga, , New Zealand

Sørlandet Sykehus Kristiansand

Kristiansand, , Norway

Oslo universitetssykehus HF, Ullevål, Kreftsenteret

Oslo, , Norway

Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

Stavanger, , Norway

Shifa International Hospital; Department of Oncology

Islamabad, , Pakistan

Aga Khan University; Department of Oncology

Karachi, , Pakistan

Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

Lahore, , Pakistan

Hameed Latif Hospital; Department of Oncology

Lahore, , Pakistan

Centro Hemato Oncologico Panama

Panama City, , Panama

Centro Medico Monte Carmelo

Arequipa, , Peru

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Clinica de Especialidades Medicas

Lima, , Peru

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Lima, , Peru

Instituto Oncologico de Lima

Lima, , Peru

Philippine General Hospital; Section Of Medical Oncology

Manila, , Philippines

East Avenue Medical Center

Quezon City, , Philippines

Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki

Krakow, , 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

Rzeszów, , Poland

Wojewodzki Szpital Zespolony

Torun, , Poland

NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna

Żory, , Poland

Centro Clinico Champalimaud; Oncologia Medica

Lisbon, , Portugal

Hospital da Luz; Departamento de Oncologia Medica

Lisbon, , Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Hospital de Sao Joao; Servico de Oncologia

Porto, , Portugal

Policlinica Sfanta Maria - Oncology; Medical Oncology

Baia Mare, , Romania

Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

Bucharest, , Romania

Emergency University Bucharest Hospital; Oncology Department

Bucharest, , Romania

Cluj Clinical County Hospital; Oncology Dept

Cluj-Napoca, , Romania

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

SC Oncolab SRL

Craiova, , Romania

Clinical Hospital 1 Craiova; Medical Oncology

Craiova, , Romania

S.C. Life Search S.R.L; Medical Oncology Clinic

Timișoara, , Romania

ONCOMED - Medical Centre

Timișoara, , Romania

Regional Oncology Hospital

Irkutsk, , Russia

City Oncological Hospital

Izhevsk, , Russia

Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

Moscow, , Russia

City Clinical Oncology Hospital

Moscow, , Russia

State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

Orenburg, , Russia

City Clinical Oncology Dispensary, SPb SBIH CCOD

Saint Petersburg, , Russia

Bashkirian Republican Clinical Oncology Dispensary

Ufa, , Russia

King Faisal Specialist Hospital & Research Centre

Jeddah, , Saudi Arabia

King Abdul Aziz Medical City, King Fahd National Guard; Oncology

Riyadh, , Saudi Arabia

Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

Belgrade, , Serbia

Institute for Onc/Rad Serbia

Belgrade, , Serbia

Oncology Institute of Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Centre Nis, Clinic for Oncology

Niš, , Serbia

National Cancer Centre; Medical Oncology

Singapore, , Singapore

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

Prešov, , Slovakia

Fakultna nemocnica Trencín; Onkologicke odd.

Trenčín, , Slovakia

University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology

Maribor, , Slovenia

Westridge Medical Center

Durban, , South Africa

Donald Gordon Medical Centre

Johannesburg, , South Africa

Steve Biko Academic Hospital; Oncology

Pretoria, , South Africa

National Cancer Center

Goyang-si, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Yonsei University Severance Hospital; Medical Oncology

Seoul, , South Korea

Asan Medical Center.

Seoul, , South Korea

Hospital General de Elda; Servicio de Oncologia

Elda, Alicante, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, Spain

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, Spain

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, Spain

Hospital Quiron de Madrid; Servicio de Oncologia

Pozuelo de Alarcón, Madrid, Spain

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, Spain

Hospital Do Meixoeiro; Servicio de Oncologia

Vigo, Pontevedra, Spain

Hospital de Cabueñes; Servicio de Oncologia

Gijón, Principality of Asturias, Spain

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife, Spain

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Lluis Alcanys; Servicio de Oncologia

Xàtiva, Valencia, Spain

Hospital de Basurto; Servicio de Oncologia

Bilbao, Vizcaya, Spain

Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia

Albacete, , Spain

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, , Spain

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, , Spain

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

Burgos, , Spain

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, , Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, , Spain

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, , Spain

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

Lleida, , Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, , Spain

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, , 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 Clinico Universitario Lozano Blesa; Servicio de Oncologia

Zaragoza, , Spain

Skånes University Hospital, Skånes Department of Onclology

Lund, , Sweden

Skaraborgs sjukhus Skoevde, Dept of surgery

Skövde, , Sweden

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

Zurich, , Switzerland

China Medical University Hospital; Surgery

Taichung, , Taiwan

National Cheng Kung Uni Hospital; Surgery

Tainan City, , Taiwan

National Taiwan Uni Hospital; General Surgery

Taipei, , Taiwan

Tri-Service General Hospital, Division of General Surgery

Taipei, , Taiwan

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, , Thailand

Ankara Uni School of Medicine; Medical Oncology

Ankara, , Turkey (Türkiye)

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, , Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, , Turkey (Türkiye)

Gaziantep Univ. Med. Fac.

Gaziantep, , Turkey (Türkiye)

Istanbul Uni of Medicine Faculty; Oncology Dept

Istanbul, , Turkey (Türkiye)

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, , Turkey (Türkiye)

Kocaeli University Faculty of Medicine; Medical oncology

İzmit, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

19 Mayis University Medical Faculty; Medical Oncology Department

Samsun, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, , Turkey (Türkiye)

Kyiv City Clinical Oncological Center; Chemotherapy Department

Kiev, , Ukraine

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

Lviv, , Ukraine

Tawam Hospital

Al Ain City, , United Arab Emirates

Nevill Hall Hospital

Abergavenny, , United Kingdom

Bedford Hospital; Oncology

Bedford, , United Kingdom

Wexham Park Hospital; Oncology

Berkshire, , United Kingdom

University Hospital Birmingham Queen Elizabeth Hospital

Birmingham, , United Kingdom

Heartlands Hospital; Department Of Medicine

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

The Clatterbridge Cancer Ctr For Oncolgy

Metropolitan Borough of Wirral, , 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 Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, , United Kingdom

Airedale General Hospital; Oncology

York, , United Kingdom

York District Hospital

York, , United Kingdom

Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

Montevideo, , Uruguay

Hospital Militar; Oncologia

Montevideo, , Uruguay

Hospital Pereira Rossell; Oncology Department

Montevideo, , Uruguay

Instituto Oncológico Luis Razetti

Caracas, , Venezuela

Centro Integral de Oncología

Caracas, , Venezuela

Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos

Caracas, , Venezuela

K hospital

Hanoi, , Vietnam

Countries

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; Lithuania; Malaysia; Mexico; Morocco; Netherlands; New Zealand; Norway; Pakistan; Panama; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Arab Emirates; United Kingdom; Uruguay; Venezuela; Vietnam

References

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.

Reference Type: DERIVED

PMID: 30018134 (View on PubMed)

Gligorov 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.

Reference Type: DERIVED

PMID: 28625777 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2011-005328-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO28048

Identifier Type: -

Identifier Source: org_study_id