Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer (HERA)

March 17, 2017 updated by: Hoffmann-La Roche

A Randomized Three-Arm, Multicenter 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

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5099

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
  • Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
  • Known hormone receptor status
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)

Exclusion Criteria:

  • Prior invasive breast carcinoma
  • Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • Clinical T4 tumors
  • Cumulative doxorubicin exposure greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or any prior anthracyclines unrelated to the present breast cancer
  • Peripheral stem cell or bone marrow stem cell support
  • Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
  • Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
  • Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
  • Poor hematologic, hepatic, or renal function
  • Pregnancy or lactation
  • Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Observation Arm
Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided.
EXPERIMENTAL: Herceptin 1-Year Arm
Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Drug: Herceptin
Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Other Names:
  • Trastuzumab
Drug: Herceptin
Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Other Names:
  • Trastuzumab
EXPERIMENTAL: Herceptin 2-Year Arm
Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Drug: Herceptin
Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Other Names:
  • Trastuzumab
Drug: Herceptin
Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.
Other Names:
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 1 year)
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
From Baseline until time of event (median of 1 year)
Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 1 year)
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
From Baseline until time of event (median of 1 year)
DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: Year 2
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
Year 2
DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: Year 2
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
Year 2
Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
From Baseline until time of event (median of 8 years)
DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Year 3
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Year 3
DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Year 5
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Year 5
DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Year 7
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Year 7
DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Year 8
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Year 8
Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: From Baseline until time of event (maximum of 10 years)
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
From Baseline until time of event (maximum of 10 years)
DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 3
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 3
DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 5
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 5
DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 7
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 7
DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 8
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 8
DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 9
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 9
DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: Year 10
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
Time Frame: From Baseline until time of event (maximum of 10 years)
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
From Baseline until time of event (maximum of 10 years)
DFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up
Time Frame: Years 3, 5, 7, 8, 9, 10
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with a 10-year maximum follow-up for DFS events.
Years 3, 5, 7, 8, 9, 10
Percentage of Participants With Overall Survival (OS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 1 year)
OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
From Baseline until time of event (median of 1 year)
Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 1 year)
OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
From Baseline until time of event (median of 1 year)
OS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: Year 2
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
Year 2
OS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
Time Frame: Year 2
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
Year 2
Percentage of Participants With OS Events Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
OS events referred to death from any cause. The percentage of participants who died was reported.
From Baseline until time of event (median of 8 years)
OS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 11 years)
OS events referred to death from any cause. The percentage of participants who died was reported.
From Baseline until time of event (median of 11 years)
OS Rate According to Kaplan-Meier Analysis Compared to Observation: 11-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 9, 10, 11, 12
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
Years 3, 5, 7, 9, 10, 11, 12
Percentage of Participants With OS Events in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 11 years)
OS events referred to death from any cause. The percentage of participants who died was reported.
From Baseline until time of event (median of 11 years)
OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 9, 10, 11, 12
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
Years 3, 5, 7, 9, 10, 11, 12
Percentage of Participants With Recurrence-Free Survival (RFS) Events Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.
From Baseline until time of event (median of 8 years)
RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With RFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
RFS events included local, regional, or distant tumor recurrence. The percentage of participants with at least one RFS event was reported.
From Baseline until time of event (median of 8 years)
RFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.
From Baseline until time of event (median of 8 years)
DDFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With DDFS Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.
From Baseline until time of event (median of 8 years)
DDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants free of DDFS events (i.e., the DDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With Tumor Recurrence (TR) Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
From Baseline until time of event (median of 8 years)
TR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
Years 3, 5, 7, 8
Percentage of Participants With TR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
The percentage of participants with TR of the present breast cancer was reported. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
From Baseline until time of event (median of 8 years)
TR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
The percentage of participants without TR of the present breast cancer (i.e., the TR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. TR included local, regional, or distant tumor ignoring contralateral breast cancer and second non-breast malignancy.
Years 3, 5, 7, 8
Percentage of Participants With Distant Tumor Recurrence (DTR) Compared to Observation: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
From Baseline until time of event (median of 8 years)
DTR-Free Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
Years 3, 5, 7, 8
Percentage of Participants With DTR in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
The percentage of participants with DTR was reported. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
From Baseline until time of event (median of 8 years)
DTR-Free Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
The percentage of participants without DTR (i.e., the DTR-free rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis. DTR included distant tumors ignoring local and regional recurrences, contralateral breast cancer, and second non-breast malignancy.
Years 3, 5, 7, 8
Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: From Baseline until time of event (median of 8 years)
RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS event was reported.
From Baseline until time of event (median of 8 years)
RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up
Time Frame: Years 3, 5, 7, 8
RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
Years 3, 5, 7, 8
Percentage of Participants With Primary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: From Baseline until time of event (maximum up to 10 years)
Primary cardiac endpoint events included the occurrence of any of the following between randomization and new therapy for recurrent disease: symptomatic New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) confirmed by a cardiologist with a drop in left ventricular ejection fraction (LVEF) at least 10 percentage points from Baseline and to a value less than (<) 50%, and documentation of definite or probable cardiac death. Definite cardiac death included CHF, myocardial infarction, or primary arrhythmia. Probable cardiac death included unexpected sudden death within 24 hours of a cardiac event (syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology. The percentage of participants with at least one primary cardiac endpoint event was reported. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.
From Baseline until time of event (maximum up to 10 years)
Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up
Time Frame: From Baseline until time of event (maximum up to 10 years)
Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value <50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.
From Baseline until time of event (maximum up to 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
ETOP IBCSG Partners Foundation
Breast International Group

Investigators

  • Study Chair: Olivia Pagani, MD, Ospedale Beata Vergine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO16348
  • BIG-01-01
  • EU-20216
  • ROCHE-B016348E
  • ROCHE-B016348C
  • EORTC-10011
  • CAN-NCIC-MA24
  • IBCSG-28-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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