Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
- Registration Number
- NCT00553410
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period.
Secondary
* Compare overall survival of patients treated with these two regimens.
* Compare distant DFS of these patients.
* Compare breast cancer-free interval of these patients.
* Compare sites of first DFS failure in these patients.
* Compare second (nonbreast) malignancies in these patients.
* Compare deaths without prior cancer events in these patients.
* Compare adverse events resulting from these two regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and type of prior endocrine therapy (selective estrogen receptor modulators \[SERMs\] alone vs aromatase inhibitors \[AIs\] alone vs both SERMs and AIs each for at least 1 month). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral letrozole daily for 5 years.
* Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through 4, followed by 12 months in year 5.
After completion of study therapy, patients are followed annually.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4884
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous letrozole Letrozole Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Intermittent letrozole Letrozole Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS) 5-year estimates, reported at a median follow-up of 60 months Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.
- Secondary Outcome Measures
Name Time Method Overall Survival 5-year estimates, reported at a median follow-up of 60 months Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).
Breast Cancer-free Interval 5-year estimates, reported at a median follow-up of 60 months Duration of time from randomization to the first indication of the following events: invasive breast recurrence at local, regional or distant sites; a new invasive cancer in the contralateral breast (second non-breast malignancies are ignored). In the absence of an event, BCFI was censored at the date of last follow-up visit or date of death without prior breast cancer event.
Distant Recurrence-free Interval (DRFI) 5-year estimates, reported at a median follow-up of 60 months Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.\*
\*This endpoint replaced DDFS, which was specified in the protocol
Trial Locations
- Locations (163)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Hanusch-Krankenhaus
🇦🇹Vienna, Austria
Armidale Hospital
🇦🇺Armidale, New South Wales, Australia
Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
A. Perrino Hospital
🇮🇹Brindisi, Italy
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Tokyo Metropolitan - Komagome Hospital
🇯🇵Tokyo, Japan
Tygerberg Hospital
🇿🇦Kapstadt, South Africa
Azienda Istituti Ospitalieri
🇮🇹Cremona, Italy
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Hospital Son Llatzer
🇪🇸Palma De Mallorca, Spain
Kumamoto University Faculty of Medical and Pharmaceutical Sciences
🇯🇵Kumamoto, Japan
Sagara Hospital
🇯🇵Kagoshima, Japan
Ospedale "la Carita", Locarno
🇨🇭Locarno, Switzerland
Tumor Zentrum ZeTup St. Gallen und Chur
🇨🇭St. Gallen, Switzerland
Lasarettet i Boras
🇸🇪Boras, Sweden
Yao Municipal Hospital
🇯🇵Osaka, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Ospedale degli Infermi - ASL 12
🇮🇹Biella, Italy
Ospedale Civile Rimini
🇮🇹Rimini, Italy
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Tata Memorial Hospital
🇮🇳Mumbai, India
Hopital Regional de Sion-Herens-Conthey
🇨🇭Sion, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Azienda Sanitaria di Bolzano
🇮🇹Bolzano, Italy
Skaraborgs Hospital
🇸🇪Skovde, Sweden
Brustzentrum Thurgau at Kantonsspital Frauenfeld
🇨🇭Frauenfeld, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Waikato Hospital
🇳🇿Hamilton, New Zealand
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Misericordia e Dolce Hospital
🇮🇹Prato, Italy
Osaka Rosai Hospital
🇯🇵Sakai, Osaka, Japan
City Hospital Triemli
🇨🇭Zurich, Switzerland
Hospital de Torrevieja
🇪🇸Torrevieja, Spain
Regionalspital
🇨🇭Thun, Switzerland
Malarsjukhuset Hospital
🇸🇪Eskilstuna, Sweden
Karolinska University Hospital - Huddinge
🇸🇪Stockholm, Sweden
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Inselspital Bern
🇨🇭Bern, Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital
🇨🇭Bern, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
European Institute of Oncology
🇮🇹Milan, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Lidkoping Hospital
🇸🇪Lidkoping, Sweden
Kyoto University Hospital
🇯🇵Kyoto, Japan
Bankstown - Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
Breast Center
🇨🇭Zurich, Switzerland
Southern Highlands Cancer Center
🇦🇺Bowral, New South Wales, Australia
Port Mcquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Tamworth Base Hospital
🇦🇺Tamworth, New South Wales, Australia
Tweed Heads Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
North West Regional Hospital
🇦🇺Burnie, Tasmania, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Landeskrankenhaus Feldkirch
🇦🇹Feldkirch, Austria
Maroondah Hospital
🇦🇺Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Krankenhaus BHS Linz
🇦🇹Linz, Austria
Allgemeines Krankenhaus Linz
🇦🇹Linz, Austria
LKH Villach
🇦🇹Villach, Austria
St. Johanns-Spital
🇦🇹Salzburg, Austria
Institut Jules Bordet
🇧🇪Brussels, Belgium
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Medical University of Vienna
🇦🇹Vienna, Austria
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
Krankenhaus Lainz
🇦🇹Vienna, Austria
Cliniques du Sud Luxembourg
🇧🇪Arlon, Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
AZ Klina
🇧🇪Brasschaat, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels, Belgium
Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg
🇧🇪Duffel, Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
AZ Groeninge - Oncologisch Centrum
🇧🇪Kortrijk, Belgium
Centre Hospitalier Hutois
🇧🇪Huy, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
Centre Hospitalier de l'Ardenne
🇧🇪Libramont, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Clinique Saint-Joseph
🇧🇪Liege, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
Jan Palfijn Hospital
🇧🇪Merksem, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
Sint-Elisabethziekenhuis
🇧🇪Turnhout, Belgium
Clinique Saint Vincent
🇧🇪Rocourt, Belgium
Hospital Santiago Oriente Dr. Luis Tisne Brousse
🇨🇱Penalolen, Chile
Centre Hospitalier Peltzer-La Tourelle
🇧🇪Verviers, Belgium
Fundacion Arturo Lopez Perez
🇨🇱Santiago, Chile
AZ Nikolaas - Sint-Niklaas
🇧🇪Sint-Niklaas, Belgium
Instituto Nacional Del Cancer
🇨🇱Santiago, Chile
Hospital Clinico San Borja Arriaran
🇨🇱Santiago, Chile
Hospital Clinico Regional de Valdivia at University Austral de Chile
🇨🇱Valdivia, Chile
Hillerod Hospital
🇩🇰Hillerod, Denmark
Centralsygehus Esbjerg
🇩🇰Esbjerg, Denmark
Herning Central Hospital
🇩🇰Herning, Denmark
IRAM - Chile
🇨🇱Santiago, Chile
Aarhus Universitetshospital - Aarhus Sygehus
🇩🇰Aarhus C, Denmark
Naestved Hospital
🇩🇰Naestved, Denmark
Hospital Carlos Van Buren
🇨🇱Valparaiso, Chile
Copenhagen County Herlev University Hospital
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Roskilde Amtssygehuset
🇩🇰Roskilde, Denmark
Bornholms Hospital
🇩🇰Ronne, Denmark
Sonderborg Sygehus
🇩🇰Sonderborg, Denmark
Vejle Sygehus
🇩🇰Vejle, Denmark
Vinzenzkrankenhaus Hannover gGmbH
🇩🇪Hannover, Germany
Viborg Sygehus
🇩🇰Viborg, Denmark
Institut Bergonie
🇫🇷Bordeaux, France
Praxis Dr. Wilke - Onkologie am Klinikum Fuerth
🇩🇪Fuerth, Germany
Onkologische Schwerpunktpraxis Bielefeld
🇩🇪Bielefeld, Germany
Klinikum Deggendorf
🇩🇪Deggendorf, Germany
Henriettenstiftung Krankenhaus
🇩🇪Hannover, Germany
Aalen Breast Center
🇩🇪Aalen, Germany
Allgemeinen Krankenhaus Celle Kinderklinik
🇩🇪Celle, Germany
Gynaekologisch-onkologische Praxis Hannover
🇩🇪Hannover, Germany
Gemeinschaftspraxis Gynaekologie & Geburtshilfe
🇩🇪Mannheim, Germany
Frauenheilkunde u. Geburtshilfe
🇩🇪Ilsede, Germany
Asklepios Klinik Lich
🇩🇪Lich, Germany
Klinikum Meiningen GmbH
🇩🇪Meiningen, Germany
Klinikum Offenback GmbH
🇩🇪Offenbach, Germany
Klinikum Memmingen
🇩🇪Memmingen, Germany
Deaconess Hospital
🇩🇪Schwabisch Hall, Germany
Johanniter Kankenhaus Stendal
🇩🇪Stendal, Germany
SRH Zentralklinikum Suhl GmbH
🇩🇪Suhl, Germany
National Institute of Oncology - Budapest
🇭🇺Budapest, Hungary
Szeged University
🇭🇺Szeged, Hungary
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
M. D. Anderson International Espana SA
🇪🇸Madrid, Spain
Sandton Oncology Medical Research
🇿🇦Sandton, South Africa
Russian Academy of Medical Sciences Cancer Research Center
🇷🇺Moscow, Russian Federation
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Instituto Valenciano De Oncologia
🇪🇸Valencia, Spain
Hospital Sant Joan de Reus
🇪🇸Reus, Spain
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Kantonsspital Freiburg
🇨🇭Freiburg, Switzerland
AndreasKlinik Cham Zug
🇨🇭Cham, Switzerland
Lago Maggiore Oncology Foundation
🇨🇭Locarno, Switzerland
Ospedale Civico
🇨🇭Lugano, Switzerland
Ospedale Beata Vergine
🇨🇭Mendrisio, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Borders General Hospital
🇬🇧Melrose, England, United Kingdom
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
Klinikum Kreuzschwestern Wels GmbH
🇦🇹Wels, Austria
Imelda vzw, Ziekenhuis
🇧🇪Bonheiden, Belgium