Trastuzumab in Treating Women With Primary Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast International Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
International Breast Cancer Study Group
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00045032
First received: September 6, 2002
Last updated: June 4, 2012
Last verified: March 2012
  Purpose

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating primary breast cancer in women who have completed adjuvant chemotherapy.

PURPOSE: This randomized phase III trial is studying two different regimens of trastuzumab and observation only to compare how well they work in treating women with breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HERA: A Randomised Three-Arm Multi-Centre Comparison Of 1 Year And 2 Years Of Herceptin Versus No Herceptin In Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
  • Distant disease-free survival [ Designated as safety issue: No ]
  • Incidence of cardiac dysfunction [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to recurrence [ Designated as safety issue: No ]
  • Time to distant recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 5043
Study Start Date: December 2001
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Compare the disease-free survival of women with HER2-positive primary breast cancer treated with trastuzumab (Herceptin®) for 1 year vs trastuzumab for 2 years vs standard supportive care.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the relapse-free survival of patients treated with these regimens.
  • Compare the distant disease-free survival of patients treated with these regimens.
  • Compare the incidence of cardiac dysfunction in patients treated with these regimens.
  • Evaluate the safety and tolerability of these regimens in these patients.

Secondary

  • Compare time to recurrence in patients treated with these regimens.
  • Compare time to distant recurrence in patients treated with these regimens.
  • Compare outcomes, in terms of disease-free survival, overall survival, recurrence-free survival, distant disease-free survival, time to recurrence, time to distant recurrence, cardiac safety, and overall safety, in patients treated with trastuzumab for 1 year vs 2 years.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive trastuzumab (Herceptin®) IV over 1.5 hours on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive trastuzumab as in arm I. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm III: Patients receive no trastuzumab. Patients may later receive trastuzumab as in arm I or arm II.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic primary invasive adenocarcinoma of the breast

    • Adequately excised
    • Axillary nodes positive or negative
    • No positive or suspicious internal mammary nodes identified by sentinel node technique that have not been irradiated
    • No supraclavicular lymph node involvement
  • HER2-positive disease with one of the following:

    • 3+ overexpression by immunohistochemistry (IHC)
    • 2+ overexpression by IHC and fluorescence in situ hybridization (FISH) with c-erbB2 gene amplification
    • c-erbB2 gene amplification by FISH
  • Previously treated with at least 3 months or 4 courses of approved neoadjuvant or adjuvant chemotherapy with or without radiotherapy
  • No synchronous bilateral or multifocal breast cancer that is not HER2-positive
  • No locally advanced or inflammatory breast cancer
  • No clinical T4 primary breast tumor
  • Prior curatively treated ipsilateral ductal carcinoma in situ of the breast is allowed
  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor status known OR
    • Estrogen receptor status known

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 2,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 2 times ULN

Cardiovascular

  • LVEF at least 55% by echocardiography or MUGA
  • No serious cardiac illness
  • No documented congestive heart failure
  • No high-risk uncontrolled arrhythmias
  • No angina pectoris requiring antianginal medication
  • No clinically significant valvular heart disease
  • No evidence of transmural infarction on EKG
  • No poorly controlled hypertension (i.e., systolic greater than 180 mm Hg or diastolic greater than 100 mm Hg)

Pulmonary

  • No severe pulmonary disease/illness

Other

  • No other malignancy except for curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer that has been curatively treated, with no evidence of disease, and has less than 15% risk of recurrence over the next 10 years
  • No other concurrent serious disease that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior peripheral stem cell or bone marrow stem cell transplantation as part of prior neoadjuvant or adjuvant chemotherapy regimen
  • No prior biologic therapy or immunotherapy for breast cancer
  • No prior anti-HER2 therapy for any reason
  • No concurrent immunotherapy for breast cancer

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • No prior cumulative dose of doxorubicin more than 360 mg/m^2 or epirubicin more than 720 mg/m^2
  • No prior anthracyclines for another malignancy
  • No more than 7 weeks since day 1 of last chemotherapy course
  • No concurrent adjuvant chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy, including aromatase inhibitors, pure antiestrogens, or progestational agents, for breast cancer
  • Concurrent systemic adjuvant hormonal therapy for estrogen receptor-positive patients allowed
  • Concurrent tamoxifen allowed

Radiotherapy

  • See Disease Characteristics
  • No more than 6 weeks since completion of prior radiotherapy
  • No prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer

Surgery

  • See Disease Characteristics
  • No more than 6 weeks since prior definitive surgery
  • Concurrent ovarian ablation allowed

Other

  • No other concurrent investigational therapy for breast cancer
  • Concurrent bisphosphonate therapy allowed if started prior to study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045032

  Hide Study Locations
Locations
Argentina
Hospital Aleman de Buenos Aires
Buenos Aires, Argentina, 1118
Australia, Australian Capital Territory
Saint John of God Hospital
Geelong, Australian Capital Territory, Australia, 3220
Australia, Queensland
Toowoomba Hospital
Toowoomba, Queensland, Australia, 4350
Australia, Victoria
Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Mount Hospital
Perth, Western Australia, Australia, 6000
Austria
Landeskrankenhaus Feldkirch
Feldkirch-Tisis, Austria, 6807
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria, 9026
St. Vincent's Hospital
Linz Donau, Austria, A-4010
Landeskrankenanstalten - Salzburg
Salzburg, Austria, A-5020
Landeskrankenhaus St. Poelten
St. Poelten, Austria, 3100
Universitaetsklinik fuer Innere Medizin I
Vienna, Austria, 1090
Wilhelminenspital der Stadt Wien
Vienna, Austria, A-1160
LKH Villach
Villach, Austria, 9500
LKH Voecklabruck
Voecklabruck, Austria, 4840
A. oe. Krankenhaus Wiener Neustadt
Wiener Neustadt, Austria, A-2700
Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Belgium, 2020
Reseau Hospitalier De Medecine Sociale
Baudour, Belgium, 7331
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Institut Jules Bordet
Brussels, Belgium, B-1000
Centre Hospitalier Notre Dame - Reine Fabiola
Charleroi, Belgium, 6000
Cazk Groeninghe - Campus St-Niklaas
Kortrijk, Belgium, B-8500
Centre Hospitalier Universitaire de Tivoli
La Louviere, Belgium, 7100
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Clinique Saint-Joseph
Liege, Belgium, B 4000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
Hospital Serruys Ziekenhuis
Oostende, Belgium, 8400
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
Brazil
Porto Alegre Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Hospital Santa Rita
Porto Alegre, Brazil, 91330-490
Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil, 90610-000
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20560-120
Faculdade De Medicina Do ABC
Santo Andre, Brazil, 09060-650
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Royal Victoria Hospital of Barrie
Barrie, Ontario, Canada, L4M 6M2
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Trillium Health Centre - Mississauga Site
Mississauga, Ontario, Canada, L5B 1B8
Algoma Regional Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, Canada, P6A 2C4
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
Canada, Prince Edward Island
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
Hospital Dr. Sotero Del Rio
Santiago, Chile
Hospital Clinico San Borja Arriaran
Santiago, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile, 29
Hospital Militar
Santiago, Chile
Instituto Nacional Del Cancer
Santiago, Chile
China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Tongji Medical University
Wuhan, China, 430030
Colombia
Instituto Nacional De Cancerologia
Bogota, Colombia
Croatia
Clinical Hospital Center Split
Split, Croatia, 21000
Denmark
Centralsygehus I Esbjerg
Esbjerg, Denmark, 6700
Herning Central Hospital
Herning, Denmark, 7400
Hillerod Hospital
Hillerod, Denmark, 3400
Centralsygehuset I Naestved
Naestved, Denmark, 4700
Sonderborg Sygehus
Sonderborg, Denmark, 6400
France
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Hopital Clinique Claude Bernard
Metz, France, 57072
Germany
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Evangelisches Bethesda Krankenhaus GmbH
Essen, Germany, D-45355
Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
Martin Luther Universitaet
Halle, Germany, D-06097
Henriettenstiftung Krankenhaus
Hanover, Germany, D-30559
Universitaets-Hautklinik Heidelberg
Heidelberg, Germany, D-69115
St. Vincentius-Kliniken
Karlsruhe, Germany, D-76137
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Kreiskrankenhaus Leonberg - Frauenklinik
Leonberg, Germany, D-71229
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, D-39120
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Frauenklinik Vom Roten Kreuz
Munich, Germany, 80637
Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt
Rostock, Germany, D-18059
Universitaet Ulm
Ulm, Germany, D-89075
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Greece
University of Crete School of Medicine
Heraklion, Crete, Greece, 71110
Evaggelismos Hospital
Athens, Greece, 10676
Guatemala
Centro Medico
Guatemala City, Guatemala, 01010
Hospital Roosevelt
Guatemala City, Guatemala, 01010
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Hungary
Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia
Budapest, Hungary, H-1032
National Institute of Oncology
Budapest, Hungary, 1122
Semmelweis University
Budapest, Hungary, 1082
Ireland
Cork University Hospital
Cork, Ireland
Israel
Sieff Hospital
Safed, Israel, 13110
Italy
Ospedale San Lazzaro
Alba, Italy, 12051
Ospedale Presenti Fenaroli
Alzano-Lombardo, Italy, 24022
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Ospedale degli Infermi - ASL 12
Biella, Italy, 13900
Ospedale Bellaria
Bologna, Italy, I-40139
Spedali Civili di Brescia
Brescia, Italy, 25124
Ospedale Oncologico A. Businco
Cagliari, Italy, 09100
Ospedale B. Ramazzini
Carpi, Italy, 41012
Ospedale Valduce
Como, Italy, 22100
Ospedale Santa Croce
Cuneo, Italy, 12100
Universita Degli Studi Di Florence
Firenze (Florence), Italy, 50121
Azienda Ospedaliero Careggi
Florence, Italy, 50139
Morgagni-Pierantoni Ospedale
Forli, Italy, 47100
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale A. Manzoni
Lecco, Italy, 23900
Presidio Ospedaliero
Livorno, Italy, 57100
Carlo Poma Hospital
Mantova, Italy, 46100
European Institute of Oncology
Milan, Italy, 20141
Ospedale Niguarda Ca'Granda
Milan, Italy, 20162
University of Modena Hospital and Reggio Emilia School of Medicine
Modena, Italy, 41100
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Policlinico Monteluce
Perugia, Italy, 06122
Azienda Ospedaliera
Reggio Emilia, Italy, 42100
Ospedale Sant' Eugenio
Rome, Italy, 00144
Ospedale San Filippo Neri
Rome, Italy, 00135
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Ospedale Civile ASL 1
Sassari, Italy, 07100
Primario U.O. di Oncologia Medica
Trento, Italy, 38100
Ospedale Ostetrico Ginecologica Sant Anna
Turin, Italy, 10126
Universita di Torino
Turin, Italy, 10126
Japan
Tokai University School Of Medicine
Kanagawa, Japan, 259-1193
Tokyo Metropolitan - Komagome Hospital
Tokyo, Japan, 113-8677
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Maasland Hospital
Sittard, Netherlands, 6131 BK
Diakonessenhuis Utrecht
Utrecht, Netherlands, 3508 TG
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Oncologic Center
Gliwice, Poland, 44-101
Medical University
Poznan, Poland, 61-878
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3000
Maternidade Byssaia Barreto
Coimbra, Portugal, 3000
Instituto Portugues de Oncologia, Centro Regional de Coimbra
Coimbra, Portugal, 3000-075
Hospital Distrital De Faro
Faro, Portugal, 8000
University Hospital of Santa Maria
Lisboa, Portugal, 1649-035
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisbon, Portugal, 1099-023 Codex
Russian Federation
Moscow Oncology Hospital
Moscow, Russian Federation, 107005
P.A. Hertzen Research Oncology Institute
Moscow, Russian Federation, 125284
Singapore
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
South Africa
Groote Schuur Hospital
Cape Town, South Africa, 7925
Parklands Hospital
Durban, South Africa, 4001
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2193
Sandton Oncology Centre
Johannesburg, South Africa, 2121
Pretoria - East Hospital
Lynnwood, South Africa, 0081
Spain
Hospital De La Ribera
Alzira, Spain, 46600
Hospital Del Mar
Barcelona, Spain, 08003
Hospital Universitario San Cecilio de Granada
Granada, Spain, 18003
Hospital General Universitario De Guadalajara
Guadalajara, Spain, 19002
Hospital Juan Ramon Jimenez
Huelva, Spain, 21005
Hospital Cuidad de Jaen
Jaen, Spain, 23007
Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro
La Coruna, Spain, 15009
Hospital Universitario Canarias
La Laguna, Spain, 38320
Hospital Insular de Gran Canaria
Las Palmas, Spain, G.C.
Hospital de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain, 35020
Hospital de la Princesa
Madrid, Spain, 28006
Complejo Hospitalario Santa Maria
Orense, Spain, 32005
Complejo Hospitalario de Pontevedra
Pontevedra, Spain, 36001
Consorci Hospitalari del Parc Tauli
Sabadell, Spain, 08208
Hospital Universitario Nuestra Senora de la Candelaria
Santa Cruz de Tenerife, Spain, 38010
Hospital Universidad Virgen Del Rocio
Sevilla, Spain, E- 41013
Hospital Virgen Del La Salud
Toledo, Spain, 45004
Hospital General Universitario Valencia
Valencia, Spain, 41014
Complexo Hospitalario Xeral de Vigo
Vigo Pontevedra, Spain, 36204
Hospital Universitario Miguel Servet
Zaragoza, Spain, 59009
Sweden
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
University Hospital of Malmoe
Malmo, Sweden, 20502
Sahlgrenska University Hospital - Molndal at Gothenburg University
Molndal, Sweden, S-43180
Karolinska University Hospital - Huddinge
Stockholm, Sweden, S-171 76
Umea Universitet
Umea, Sweden, SE-901 87
Uppsala University Hospital
Uppsala, Sweden, SE-75185
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Spitaeler Chur AG
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Thailand
Chulalongkorn University Hospital
Bangkok, Thailand, 10330
Ramathibodi Hospital
Bangkok, Thailand, 10400
United Kingdom
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom, BD9 6RJ
Broomfield Hospital
Chelmsford, Essex, England, United Kingdom, CM1 7ET
Saint Margaret's Hospital
Epping Essex, England, United Kingdom, CM16 6TN
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom, DN33 2BA
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Princess Royal Hospital
Hull, England, United Kingdom, HU8 9HE
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS16 6QB
Imperial College of Medicine
London, England, United Kingdom, W12 0NN
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Airedale General Hospital
West Yorkshire, England, United Kingdom, BD20 6TD
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Sponsors and Collaborators
Hoffmann-La Roche
Breast International Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
International Breast Cancer Study Group
Investigators
Study Chair: Martine J. Piccart-Gebhart, MD, PhD Institut Jules Bordet
Study Chair: Robert E. Coleman, MD, FRCP Cancer Research Centre at Weston Park Hospital
Study Chair: Karen A. Gelmon, MD British Columbia Cancer Agency
Study Chair: Kathleen I. Pritchard, MD Odette Cancer Centre at Sunnybrook
Study Chair: Olivia Pagani, MD Ospedale Beata Vergine
  More Information

Additional Information:
Publications:
McCaskill-Stevens W, Procter M, Goodbrand J, et al.: Disease-free survival according to local immunohistochemistry for HER2 and central fluorescence in situ hydridization for patients treated with adjuvant chemotherapy with and without trastuzumab in the HERA (BIG 01-01) trial. [Abstract] Breast Cancer Res Treat 106 (1): A-71, S18, 2007.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00045032     History of Changes
Other Study ID Numbers: BO16348, BIG-01-01, EU-20216, ROCHE-B016348E, ROCHE-B016348C, EORTC-10011, CAN-NCIC-MA24, IBCSG-28-02
Study First Received: September 6, 2002
Last Updated: June 4, 2012
Health Authority: Sweden: Swedish Medical Products Agency

Keywords provided by Hoffmann-La Roche:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014