NCT01566721

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,577

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2012

Longer than P75 for phase_3

Geographic Reach
55 countries

428 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.8 years

First QC Date

March 22, 2012

Results QC Date

March 6, 2017

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (5)

  • Percentage of Participants Who Died by Data Cutoff of 10 March 2015

    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

    From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)

  • Disease-Free Survival Rate

    From Baseline to time of event (up to approximately 8 years)

  • Overall Survival Rate

    From Baseline to Time of Event (Up to Approximately 6 Years)

  • Percentage of Participants by Item Response to SID Satisfaction Questionnaire

    Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

Study Arms (2)

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.

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.

Drug: Herceptin

Interventions

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

Also known as: Trastuzumab
Cohort A: SC Herceptin by Needle/SyringeCohort B: SC Herceptin by SID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (437)

University "Mother Theresa" Hospital Center; Oncology Department

Tirana, 1000, Albania

Location

CPMC; Service d'Oncologie Médicale

Algiers, 16000, Algeria

Location

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, C1125ABD, Argentina

Location

Hospital Britanico; Oncologia

Buenos Aires, C1280AEB, Argentina

Location

Instituto De Investigaciones Clinicas Zarate

Zárate, 2800, Argentina

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St George Hospital; Cancer Care Centre

Kogarah, New South Wales, 2217, Australia

Location

Prince of Wales Hospital; Oncology

Randwick, New South Wales, 2031, Australia

Location

Princess Alexandra Hospital; Division of Cancer Services

Woolloongabba, Queensland, 4102, Australia

Location

Queen Elizabeth Hospital; Medical Oncology

Woodville South, South Australia, 5011, Australia

Location

Western Hospital

Footscray, Victoria, 3011, Australia

Location

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Cabrini Medical Centre; Oncology

Malvern, Victoria, 3144, Australia

Location

Royal Perth Hospital; Department of Medical Oncology

Perth, Western Australia, 6000, Australia

Location

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, 7100, Bosnia and Herzegovina

Location

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Centro de Oncologia da Bahia - CENOB

Salvador, Estado de Bahia, 41820-021, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-120, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Perola Byington

São Paulo, São Paulo, 01317-000, Brazil

Location

Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

Plovdiv, 4004, Bulgaria

Location

MHAT Serdika; Department of medical oncology

Sofia, 1303, Bulgaria

Location

SHATOD - Sofia

Sofia, 1784, Bulgaria

Location

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, L1G 2B9, Canada

Location

St. Michael'S Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CSSS champlain - Charles-Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Mcgill University - Royal Victoria Hospital; Oncology

Montreal, Quebec, H3A 1A1, Canada

Location

Centro Oncológico Antofagasta

Antofagasta, 1240000, Chile

Location

Instituto Nacional del Cancer

Santiago, 8380000, Chile

Location

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4800827, Chile

Location

Hospital Carlos Van Buren, Servicio de Oncologia

Valparaíso, 2341391, Chile

Location

Clinica del Country

Bogotá, 11001, Colombia

Location

Clínica Imbanaco; Oncology

Cali, Colombia

Location

Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

Osijek, 31000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Masarykův onkologický ústav; Klinika komplexní onkologické péče

Brno, 656 53, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

Prague, 150 06, Czechia

Location

Hospital Metropolitano de Santiago

Santiago de los Caballeros, 51000, Dominican Republic

Location

Instituto de Cáncer SOLCA Cuenca; Oncología

Cuenca, EC010107, Ecuador

Location

Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

Guayaquil, EC090112, Ecuador

Location

Hospital Solca Quito; Oncologia

Quito, EC170124, Ecuador

Location

Alexandria Uni ; Medical Oncology

Alexandria, 11737, Egypt

Location

Manial Specialized Hospital; Oncology

Cairo, 11555, Egypt

Location

Nci; Oncology Dept

Cairo, 11796, Egypt

Location

Hospital Oncologia; Oncology

San Salvador, 01101, El Salvador

Location

HOPITAL JEAN MINJOZ; Oncologie

Besançon, 25030, France

Location

Clinique Tivoli; Sce Radiotherapie

Bordeaux, 33000, France

Location

Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

Bordeaux, 33077, France

Location

Ch De Fleyriat; Pneumologie 1

Bourg-en-Bresse, 01012, France

Location

Hopital Augustin Morvan; Federation De Cancerologie

Brest, 29200, France

Location

Ch De Brive La Gaillarde; Radiotherapie Oncologie

Brive-la-Gaillarde, 19312, France

Location

Clinique Sainte Marie; Chimiotherapie

Chalon-sur-Saône, 71100, France

Location

Fondation Clement Drevon; Oncology

Dijon, 21000, France

Location

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

Dijon, 21034, France

Location

Ch De La Dracenie; Hopital De Jour

Draguignan, 83007, France

Location

Hopital Prive Drome Ardeche; Chir 2A 2B

Guilherand-Granges, 07500, France

Location

Clinique Sainte Marguerite; Oncologie Medicale

Hyères, 83400, France

Location

CHD Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Hopital Albert Michallon; Oncologie

La Tronche, 38700, France

Location

Ch Du Mans; Medecine Hematologie Oncologie

Le Mans, 72037, France

Location

Clinique Victor Hugo

LeMans, 72000, France

Location

Centre Hartmann

Levallois-Perret, 92300, France

Location

Polyclinique Du Bois; Centre Bourgogne

Lille, 59000, France

Location

Hopital Claude Huriez; Medecine Interne Oncologie

Lille, 59037, France

Location

Ch Bretagne Sud Site Scorff; Oncologie Medicale

Lorient, 56100, France

Location

CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

Lorient, 56322, France

Location

Ctre Consultations La Sauvegarde

Lyon, 69338, France

Location

Hôpital Saint Joseph; Oncologie Medicale

Marseille, 13285, France

Location

Hopital Clinique Claude Bernard; Oncologie Medicale

Metz, 57000, France

Location

CHRA;Hematologie

Metz-Tessy, 74370, France

Location

Clinique Clementville; Hopital De Jour

Montpellier, 34070, France

Location

Centre Azureen De Cancerologie; Cons externes

Mougins, 06250, France

Location

Centre Antoine Lacassagne; B3 Medecine Conventionnelle

Nice, 06189, France

Location

Hopital Cochin; Unite Fonctionnelle D Oncologie

Paris, 75014, France

Location

Hopital Hotel Dieu; Oncologie Medicale

Paris, 75181, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Ch Francois Mitterrand; Medecine Oncologie

Pau, 64046, France

Location

Ch Lyon Sud; Onco Secteur Jules Courmont

Pierre-Bénite, 69495, France

Location

Chp Saint Gregoire; Cancerologie Radiotherapie

Saint-Grégoire, 35768, France

Location

Ico Rene Gauducheau; Oncologie

Saint-Herblain, 44805, France

Location

Clinique de L'Union; Oncologie

Saint-Jean, 31240, France

Location

CMCO De La Cote D Opale; Auberge De Jour

Saint-Martin-Boulogne, 62280, France

Location

Institut de Cancerologie de La Loire; Pneumologie

Saint-Priest-en-Jarez, 42270, France

Location

Ch De Saint Quentin; Medecine B10

Saint-Quentin, 02321, France

Location

Centre Paul Strauss; Oncologie Medicale

Strasbourg, 67065, France

Location

Hopitaux Du Leman Site Thonon; Maternite Gynecologie

Thonon-les-Bains, 74203, France

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

Clinique Pasteur; Pneumologie

Toulouse, 31076, France

Location

Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie

Valenciennes, 59326, France

Location

Centre-Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Klinikum Augsburg; Frauenklinik

Augsburg, 86156, Germany

Location

Internist; Praxis Für Haemotologie & Onkologie

Bad Soden, 65812, Germany

Location

Praxis Dres. Schilling & Till

Berlin, 10317, Germany

Location

Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

Berlin, 10967, Germany

Location

Katholische Hospitalvereinigung Ostwestfalen gGmbH

Bielefeld, 33615, Germany

Location

Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

Bochum, 44787, Germany

Location

Praxis Dr.med. Katja Ziegler-Löhr

Cologne, 50679, Germany

Location

St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

Cologne, 50935, Germany

Location

Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

Cologne, 51067, Germany

Location

DONAU ISAR Klinikum Deggendorf; Frauenklinik

Deggendorf, 94469, Germany

Location

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, 45122, Germany

Location

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

Essen, 45136, Germany

Location

Universitätsklinikum Freiburg; Frauenklinik

Freiburg im Breisgau, 79106, Germany

Location

Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe

Georgsmarienhütte, 49124, Germany

Location

Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

Halle, 06110, Germany

Location

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

Hamburg, 20246, Germany

Location

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, 20357, Germany

Location

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

Hanover, 30177, Germany

Location

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

Hanover, 30625, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

Jena, 07747, Germany

Location

Elisabeth-Krankenhaus Brustzentrum

Kassel, 34117, Germany

Location

Klinikum Kulmbach; Frauenklinik

Kulmbach, 95326, Germany

Location

Dres. Andreas Köhler und Roswitha Fuchs

Langen, 63225, Germany

Location

Klinikum Leverkusen; Med. Klinik III / Onkologie

Leverkusen, 51375, Germany

Location

Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe

Ludwigsburg, 71640, Germany

Location

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

Lübeck, 23538, Germany

Location

Onkologische Schwerpunktpraxis Lübeck

Lübeck, 23562, Germany

Location

Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

Mainz, 55131, Germany

Location

Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

Marburg, 35037, Germany

Location

Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

Meiningen, 98617, Germany

Location

Klinikum Memmingen; Abt.Gynäkologie

Memmingen, 87700, Germany

Location

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

Minden, 32429, Germany

Location

Praxis Dr.med. Steffi Busch

Mühlhausen, 99974, Germany

Location

Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

München, 80638, Germany

Location

Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik

München, 81925, Germany

Location

Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

Münster, 48149, Germany

Location

Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

Neuruppin, 16816, Germany

Location

Klinikum Nord Frauenklinik

Nuremberg, 90419, Germany

Location

Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

Offenbach, 63069, Germany

Location

medius KLINIK OSTFILDERN-RUIT; Brustzentrum

Ostfildern, 73760, Germany

Location

Oncologianova GmbH

Recklinghausen, 45659, Germany

Location

Agaplesion Diakonieklinikum Rotenburg

Rotenburg (Wümme), 27356, Germany

Location

Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

Saarbrücken, 66113, Germany

Location

Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

Schweinfurt, 97422, Germany

Location

HELIOS Klinikum Schwerin; Frauenklinik

Schwerin, 19049, Germany

Location

Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

Stendal, 39576, Germany

Location

Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

Torgau, 04860, Germany

Location

Universitätsklinik Tübingen; Frauenklinik

Tübingen, 72076, Germany

Location

Katharinen-Hospital gGmbH

Unna, 59423, Germany

Location

GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

Weinheim, 69469, Germany

Location

ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH

Weißenfels, 06667, Germany

Location

Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

Wetzlar, 35578, Germany

Location

Gesellschaft für Medizinische Studien Würselen

Würselen, 52146, Germany

Location

Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth

Alexandroupoli, 681 00, Greece

Location

Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

Athens, 115 22, Greece

Location

Laiko General Hospital; 1St Pathological Clinic

Athens, 115 27, Greece

Location

Alexandras General Hospital of Athens; Oncology Department

Athens, 115 28, Greece

Location

Periph. University General Hospital of Heraklion Crete; Oncology Department

Heraklion, 711 10, Greece

Location

Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

Kifissia, 145 64, Greece

Location

University Hospital of Larissa; Oncology

Larissa, 413 35, Greece

Location

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546450, Greece

Location

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, 564 29, Greece

Location

Centro Oncológico Sixtino / Centro Oncológico SA

Guatemala City, 01010, Guatemala

Location

Grupo Angeles

Guatemala City, 01015, Guatemala

Location

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, Hong Kong

Location

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, Hong Kong

Location

Szent Margit Hospital; Dept. of Oncology

Budapest, 1032, Hungary

Location

Szent Imre Hospital; Dept. of Oncology

Budapest, 1115, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

Budapest, 1125, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

Debrecen, 4032, Hungary

Location

Josa Andras Korhaz; Dept of Oncoradiology

Nyíregyháza, 4400, Hungary

Location

Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

Pécs, 7623, Hungary

Location

Markusovszky Hospital

Szombathely, 9700, Hungary

Location

Hasan Sadikin Hospital; Internal Medicine

Bandung, 40161, Indonesia

Location

CiptoMangunkusumo Hospital; Internal Medicine

Central Jakarta, 10430, Indonesia

Location

Soetomo Hospital; Surgery

East Java, 60286, Indonesia

Location

Dharmais National Cancer Center

Jakarta, 11420, Indonesia

Location

Sardjito Hospital; Instalasi Kanker Tulip

Yogyakarta, 55284, Indonesia

Location

Mater Misericordiae Uni Hospital; Oncology

Dublin, 7, Ireland

Location

Mater Private Hospital

Dublin, 7, Ireland

Location

Beaumont Hospital; Cancer Clinical Trials Unit

Dublin, 9, Ireland

Location

University Hospital Limerick

Limerick, Ireland

Location

Sligo General Hospital; Oncology

Sligo, Ireland

Location

Waterford Regional Hospital; Department Of Medical Oncology

Waterford, Ireland

Location

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, 70124, Italy

Location

Ospedale Vito Fazzi; Div. Oncoematologia

Lecce, Apulia, 73100, Italy

Location

IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

San Giovanni Rotondo, Apulia, 71013, Italy

Location

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

Rionero in Vulture, Basilicate, 85028, Italy

Location

Azienda Ospedaliera A. Cardarelli

Napoli, Campania, 80131, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

Napoli, Campania, 80131, Italy

Location

Università degli Studi Federico II; Clinica di Oncologia Medica

Napoli, Campania, 80131, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

Parma, Emilia-Romagna, 43100, Italy

Location

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

Piacenza, Emilia-Romagna, 29100, Italy

Location

Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

Ravenna, Emilia-Romagna, 48100, Italy

Location

Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

Frosinone, Lazio, 03100, Italy

Location

IFO - Istituto Regina Elena; Oncologia Medica

Rome, Lazio, 00144, Italy

Location

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

Rome, Lazio, 00161, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, 00189, Italy

Location

Ospedale Belcolle Di Viterbo; Oncologia

Viterbo, Lazio, 01100, Italy

Location

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, 24127, Italy

Location

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

Cremona, Lombardy, 26100, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

ASST DI MONZA; Oncologia Medica

Monza, Lombardy, 20900, Italy

Location

IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia

Pavia, Lombardy, 27100, Italy

Location

IRCCS Istituto Clinico Humanitas; Oncologia

Rozzano, Lombardy, 20089, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

Ospedale Oncologico A.Businco; Div. Oncologia Medica II

Cagliari, Sardinia, 09121, Italy

Location

Ospedale Civile SS Annunziata; oncologia medica

Sassari, Sardinia, 07100, Italy

Location

Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare

Catania, Sicily, 95100, Italy

Location

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

Florence, Tuscany, 50139, Italy

Location

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

Pisa, Tuscany, 56100, Italy

Location

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

Pontedera, Tuscany, 56025, Italy

Location

Ospedale Civile; Oncologia Medica

Camposampiero, Veneto, 35012, Italy

Location

Arcispedale S.Anna; Oncologia Medica

Cona (Ferrara), Veneto, 44124, Italy

Location

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Klaipeda University Hospital

Klaipėda, 92288, Lithuania

Location

Hospital Wanita dan Kanak-Kanak Sabah

Sabah, Sabah, 88996, Malaysia

Location

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

Sarawak, Sarawak, 93586, Malaysia

Location

Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi

George Town, 10990, Malaysia

Location

University Malaya Medical Centre; Clinical Oncology Unit,

Kuala Lumpur, 59100, Malaysia

Location

Centro Estatal de Oncología de Campeche

Campeche, 24096, Mexico

Location

Centro Estatal de Cancerología

Chihuahua City, 31000, Mexico

Location

Instituto Nacional de Cancerologia; Oncology

Distrito Federal, 14080, Mexico

Location

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

Mexico City, 03100, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Location

Cancerologia de Queretaro; Oncologia

Queretaro, Queretaro, 76090, Mexico

Location

Centro Estatal de Cancerologia de Nayarit

Tepic, 63170, Mexico

Location

Institut National D'oncologie Sidi Med Benabdellah

Rabat, 6213, Morocco

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

AC Amsterdam, 1091, Netherlands

Location

Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde

Apeldoorn, 7334 DZ, Netherlands

Location

Rijnstate Ziekenhuis; Inwendige Geneeskunde

Arnhem, 6815 AD, Netherlands

Location

Albert Schweitzer Ziekenhuis - loc Dordrecht

Dordrecht, 3318 AT, Netherlands

Location

Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

Ede, 6716 RP, Netherlands

Location

Catharina Ziekenhuis; Dept of Internal Medicin

Eindhoven, 5623 EJ, Netherlands

Location

Maxima Medisch Centrum; Inwendige Geneeskunde

Eindhoven, 5631 BM, Netherlands

Location

Martini Ziekenhuis; Dept of Internal Medicine

Groningen, 9728 NT, Netherlands

Location

Atrium Medisch Centrum Parkstad, Heerlen

Heerlen, 6419 PC, Netherlands

Location

Spaarne Ziekenhuis; Inwendige Geneeskunde

Hoofddorp, 2134 TM, Netherlands

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Franciscus Ziekenhuis

Roosendaal, 4708 AE, Netherlands

Location

Maasstad ziekenhuis; Afdeling oncologie hematologie

Rotterdam, 3079 DZ, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde

Schiedam, 3100 AE, Netherlands

Location

Zuyderland ziekenhuis locatie Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Diakonessenhuis Utrecht: ziekenhuisapotheek

Utrecht, 3582 KE, Netherlands

Location

Ziekenhuis VieCurie Vitaal

Venlo, 5912 BL, Netherlands

Location

Zaans Medisch Centrum

Zaandam, 1502 DV, Netherlands

Location

Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

Tauranga, 3112, New Zealand

Location

Sørlandet Sykehus Kristiansand

Kristiansand, 4604, Norway

Location

Oslo universitetssykehus HF, Ullevål, Kreftsenteret

Oslo, 0450, Norway

Location

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

Stavanger, 4011, Norway

Location

Shifa International Hospital; Department of Oncology

Islamabad, 44000, Pakistan

Location

Aga Khan University; Department of Oncology

Karachi, 74800, Pakistan

Location

Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

Lahore, 54000, Pakistan

Location

Hameed Latif Hospital; Department of Oncology

Lahore, 54600, Pakistan

Location

Centro Hemato Oncologico Panama

Panama City, 0832, Panama

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Clinica de Especialidades Medicas

Lima, Lima 41, Peru

Location

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

Lima, Lima 41, Peru

Location

Instituto Oncologico de Lima

Lima, Lima27, Peru

Location

Philippine General Hospital; Section Of Medical Oncology

Manila, 1000, Philippines

Location

East Avenue Medical Center

Quezon City, 1100, Philippines

Location

Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki

Krakow, 30-688, Poland

Location

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

Otwock, 05-400, Poland

Location

Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

Poznan, 60-569, Poland

Location

Wielkopolskie Centrum Onkologi

Poznan, 61-866, Poland

Location

MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

Rzeszów, 35-021, Poland

Location

Wojewodzki Szpital Zespolony

Torun, 87-100, Poland

Location

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

Żory, 44-240, Poland

Location

Centro Clinico Champalimaud; Oncologia Medica

Lisbon, 1400-038, Portugal

Location

Hospital da Luz; Departamento de Oncologia Medica

Lisbon, 1500-650, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Hospital de Sao Joao; Servico de Oncologia

Porto, 4200-319, Portugal

Location

Policlinica Sfanta Maria - Oncology; Medical Oncology

Baia Mare, 430241, Romania

Location

Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

Bucharest, 022328, Romania

Location

Emergency University Bucharest Hospital; Oncology Department

Bucharest, 050098, Romania

Location

Cluj Clinical County Hospital; Oncology Dept

Cluj-Napoca, 400006, Romania

Location

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

SC Oncolab SRL

Craiova, 200385, Romania

Location

Clinical Hospital 1 Craiova; Medical Oncology

Craiova, 200642, Romania

Location

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

Timișoara, 300167, Romania

Location

ONCOMED - Medical Centre

Timișoara, 300239, Romania

Location

Regional Oncology Hospital

Irkutsk, 664035, Russia

Location

City Oncological Hospital

Izhevsk, 426009, Russia

Location

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

Moscow, 115478, Russia

Location

City Clinical Oncology Hospital

Moscow, 143423, Russia

Location

State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

Orenburg, 460021, Russia

Location

City Clinical Oncology Dispensary, SPb SBIH CCOD

Saint Petersburg, 198255, Russia

Location

Bashkirian Republican Clinical Oncology Dispensary

Ufa, 450054, Russia

Location

King Faisal Specialist Hospital & Research Centre

Jeddah, 21499, Saudi Arabia

Location

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

Riyadh, 22490, Saudi Arabia

Location

Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

Belgrade, 11000, Serbia

Location

Institute for Onc/Rad Serbia

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Centre Nis, Clinic for Oncology

Niš, 18000, Serbia

Location

National Cancer Centre; Medical Oncology

Singapore, 169610, Singapore

Location

Mammacentrum sv. Agáty

Banská Bystrica, 974 01, Slovakia

Location

National Cancer Institute - Comenius University; Dept. Clinical Oncology

Bratislava, 811 05, Slovakia

Location

Vychodoslovensky onkologicky ustav

Košice, 040 01, Slovakia

Location

Fakultna nemocnica s poliklinikou J.A. Reimana Presov

Prešov, 081 81, Slovakia

Location

Fakultna nemocnica Trencín; Onkologicke odd.

Trenčín, 911 71, Slovakia

Location

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

Maribor, 2000, Slovenia

Location

Westridge Medical Center

Durban, 4058, South Africa

Location

Donald Gordon Medical Centre

Johannesburg, 2193, South Africa

Location

Steve Biko Academic Hospital; Oncology

Pretoria, 0002, South Africa

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Samsung Medical Center

Seoul, (0)6351, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Yonsei University Severance Hospital; Medical Oncology

Seoul, 120-752, South Korea

Location

Asan Medical Center.

Seoul, 138-736, South Korea

Location

Hospital General de Elda; Servicio de Oncologia

Elda, Alicante, 03600, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, 08916, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35020, Spain

Location

Hospital Quiron de Madrid; Servicio de Oncologia

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, 31008, Spain

Location

Hospital Do Meixoeiro; Servicio de Oncologia

Vigo, Pontevedra, 36214, Spain

Location

Hospital de Cabueñes; Servicio de Oncologia

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital Lluis Alcanys; Servicio de Oncologia

Xàtiva, Valencia, 46800, Spain

Location

Hospital de Basurto; Servicio de Oncologia

Bilbao, Vizcaya, 48013, Spain

Location

Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia

Albacete, 02006, Spain

Location

Hospital General Univ. de Alicante; Servicio de Oncologia

Alicante, 3010, Spain

Location

Hospital del Mar; Servicio de Oncologia

Barcelona, 08003, Spain

Location

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

Barcelona, 08041, Spain

Location

Hospital Duran i Reynals; Oncologia

Barcelona, 08907, Spain

Location

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

Burgos, 09006, Spain

Location

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, 10003, Spain

Location

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

Jaén, 23007, Spain

Location

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, 24071, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

Lleida, 25198, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

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

Madrid, 28050, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, 30120, Spain

Location

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

Toledo, 45004, Spain

Location

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, 46015, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

Zaragoza, 50009, Spain

Location

Skånes University Hospital, Skånes Department of Onclology

Lund, 221 85, Sweden

Location

Skaraborgs sjukhus Skoevde, Dept of surgery

Skövde, 54185, Sweden

Location

Hirslanden Medical Center, Tumorzentrum

Aarau, 5000, Switzerland

Location

Kantonsspital Baden; Frauenklinik

Baden, 5405, Switzerland

Location

Ospedale San Giovanni; Oncologia

Bellinzona, 6500, Switzerland

Location

Inselspital Bern; Universitätsklinik für medizinische Onkologie

Bern, 3010, Switzerland

Location

Kantonsspital Frauenfeld, Frauenklinik Thurgau

Frauenfeld, 8501, Switzerland

Location

CHUV; Departement d'Oncologie

Lausanne, 1011, Switzerland

Location

Spital Thun; Medizinische Klinik

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur; Medizinische Onkologie

Winterthur, 8401, Switzerland

Location

Stadtspital Triemli; Frauenklinik

Zurich, 8063, Switzerland

Location

China Medical University Hospital; Surgery

Taichung, 404, Taiwan

Location

National Cheng Kung Uni Hospital; Surgery

Tainan, 704, Taiwan

Location

National Taiwan Uni Hospital; General Surgery

Taipei, 100, Taiwan

Location

Tri-Service General Hospital, Division of General Surgery

Taipei, 114, Taiwan

Location

Department of Surgery, King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Pramongkutklao Hospital; Medicine - Medical Oncology Unit

Bangkok, 10400, Thailand

Location

Rajvithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital; Medicine/Oncology

Bangkok, 10400, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

Chiang Mai, 50200, Thailand

Location

Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine

Dusit, 10300, Thailand

Location

Ankara Uni School of Medicine; Medical Oncology

Ankara, 06590, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, 07070, Turkey (Türkiye)

Location

Dicle University Faculty of Medicine

Diyarbakır, 21280, Turkey (Türkiye)

Location

Gaziantep Univ. Med. Fac.

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul Uni of Medicine Faculty; Oncology Dept

Istanbul, 34390, Turkey (Türkiye)

Location

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, 34890, Turkey (Türkiye)

Location

Kocaeli University Faculty of Medicine; Medical oncology

İzmit, 31380, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

Location

19 Mayis University Medical Faculty; Medical Oncology Department

Samsun, 55139, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Location

Kyiv City Clinical Oncological Center; Chemotherapy Department

Kiev, 03115, Ukraine

Location

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

Lviv, 79031, Ukraine

Location

Tawam Hospital

Al Ain City, 15258, United Arab Emirates

Location

Nevill Hall Hospital

Abergavenny, NP7 7EG, United Kingdom

Location

Bedford Hospital; Oncology

Bedford, MK42 9DJ, United Kingdom

Location

Wexham Park Hospital; Oncology

Berkshire, SL2 4HL, United Kingdom

Location

University Hospital Birmingham Queen Elizabeth Hospital

Birmingham, B17 0NH, United Kingdom

Location

Heartlands Hospital; Department Of Medicine

Birmingham, B9 5SS, United Kingdom

Location

Royal Bournemouth Hospital; Oncology

Bournemouth, BH7 7DW, United Kingdom

Location

Kent & Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

Broomfield Hospital; Oncology

Chelmsford, CM1 7ET, United Kingdom

Location

Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr

Denbighshire, LL18 5UJ, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

North Devon District Hospital

Devon, EX31 4JB, United Kingdom

Location

Russells Hall Hospital; Oncology

Dudley, DY1 2HQ, United Kingdom

Location

University Hospital of North Durham

Durham, DH15TW, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Inverclyde Hospital

Greenock, PA16 0XN, United Kingdom

Location

Diana Princess of Wales Hosp.

Grimsby, DN33 2BA, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Princess Alexandra Hospital; Oncology Department

Harlow, CM20 1QX, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, HD3 3EA, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

Location

Crosshouse Hospital; Dept of Oncology

Kilmarnock, KA2 0BE, United Kingdom

Location

Forth Valley Royal Hospital ; Oncology Department

Larbert, FK5 4QE, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

St John's Hospital

Livingston, EH54 6PP, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, SE1 9RT, United Kingdom

Location

Queen Elizabeth Hospital

London, SE18 4QH, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, SK10 3BL, United Kingdom

Location

Christie Hospital; Breast Cancer Research Office

Manchester, M20 4QL, United Kingdom

Location

The Clatterbridge Cancer Ctr For Oncolgy

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Freeman Hospital; Northern Centre For Cancer Care

New Castle Upon Tyne, NE7 7DN, United Kingdom

Location

Royal Gwent Hospital

Newport, NP20 2UB, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE29 8NH, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, NN1 5BD, United Kingdom

Location

Derriford Hospital; Plymouth Oncology Centre

Plymouth, PL6 8DH, United Kingdom

Location

Poole General Hospital

Poole, BH15 2JB, United Kingdom

Location

Queen Alexandra Hospital, Portsmouth

Portsmouth, PO6 3LY, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Queens Hospital; R&D

Romford, RM7 0AE, United Kingdom

Location

Scarborough General Hospital

Scarborough, YO12 6QL, United Kingdom

Location

Royal Shrewsbury Hospital; Pharmacy Department

Shrewsbury, SY3 8XQ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Singleton Hospital; Pharmacy Department

Swansea, SA2 8QA, United Kingdom

Location

Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

Swindon, SN3 6BB, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

Royal Hampshire County Hospital; Winchester & Andover Breast Unit

Winchester, SO22 5DG, United Kingdom

Location

The Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Airedale General Hospital; Oncology

York, BD20 6TD, United Kingdom

Location

York District Hospital

York, YO31 8HE, United Kingdom

Location

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

Montevideo, 11400, Uruguay

Location

Hospital Militar; Oncologia

Montevideo, 11600, Uruguay

Location

Hospital Pereira Rossell; Oncology Department

Montevideo, 11600, Uruguay

Location

Instituto Oncológico Luis Razetti

Caracas, 1010, Venezuela

Location

Centro Integral de Oncología

Caracas, 1060, Venezuela

Location

Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos

Caracas, 1080, Venezuela

Location

K hospital

Hanoi, 100000, Vietnam

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 29, 2012

Study Start

May 17, 2012

Primary Completion

March 10, 2015

Study Completion

February 19, 2020

Last Updated

April 27, 2021

Results First Posted

April 18, 2017

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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).

Locations