In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat
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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIPreventionActivePostmenopausalOtherCDR0000574249
IBCSG 35-07, BIG 1-07 SOLE, 2007-001370-88, EUDRACT-2007-001370-88, EU-20772, NCT00553410

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the following criteria:
  • Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone receptor), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
  • Prior local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease
  • Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
  • Clinically disease-free
  • Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs), or a sequential combination of both
  • When calculating 4-6 years, neoadjuvant endocrine therapy should not be included
  • No evidence of recurrent disease or distant metastatic disease
  • No prior bilateral breast cancer

PATIENT CHARACTERISTICS:

  • Female
  • Must be postmenopausal by any of the following criteria:
  • Patients of any age who have had a bilateral oophorectomy (including radiation castration AND amenorrheic for > 3 months)
  • Patients 56 years old or older with any evidence of ovarian function must have biochemical evidence of definite postmenopausal status (defined as estradiol, luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the postmenopausal range)
  • Patients 55 years old or younger must have biochemical evidence of definite postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal range)
  • Patients who have received prior luteinizing-hormone releasing-hormone (LHRH) analogues within the last year are eligible if they have definite evidence of postmenopausal status as defined above
  • Clinically adequate hepatic function
  • No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy
  • No prior or current malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or ipsilateral in situ breast carcinoma
  • No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
  • No psychiatric, addictive, or any other disorder that compromises compliance with protocol requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 12 months since prior and no other concurrent endocrine SERM/AI therapy
  • Any type of prior adjuvant therapy allowed including, but not limited to, any of the following:
  • Neoadjuvant chemotherapy
  • Neoadjuvant endocrine therapy
  • Adjuvant chemotherapy
  • Trastuzumab (Herceptin®)
  • Ovarian ablation
  • Gonadotropin releasing hormone analogues
  • Lapatinib ditosylate
  • No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of bone loss), or any other investigational agent

Trial Contact Information

Trial Lead Organizations/Sponsors

International Breast Cancer Study Group

Marco ColleoniStudy Chair

Trial Sites

U.S.A.
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Harold J. Burstein, MD, PhD Ph: 617-632-2624
  Email: hburstein@partners.org
 Faulkner Hospital
 Harold J. Burstein, MD, PhD Ph: 617-632-2624
Australia
  Christchurch
 Christchurch Hospital
 Contact Person Ph: 61-2-4985-0166
  Perth
 Royal Perth Hospital
 Contact Person Ph: 61-2-4985-0166
New South Wales
  Armidale
 Armidale Hospital
 Contact Person Ph: 61-2-4985-0166
  Bankstown
 Bankstown - Lidcombe Hospital
 Contact Person Ph: 61-2-4985-0166
  Bowral
 Southern Highlands Cancer Center
 Contact Person Ph: 61-2-4985-0166
  Concord
 Concord Repatriation General Hospital
 Contact Person Ph: 61-2-4985-0166
  Gateshead
 Breast Center
 Contact Person Ph: 61-2-4985-0166
  Port Macquarie
 Port Mcquarie Base Hospital
 Contact Person Ph: 61-2-4985-0166
  Randwick
 Prince of Wales Private Hospital
 Contact Person Ph: 61-2-4985-0166
  Tamworth
 Tamworth Base Hospital
 Contact Person Ph: 61-2-4985-0166
  Tweed Heads
 Tweed Heads Hospital
 Contact Person Ph: 61-2-4985-0166
  Waratah
 Newcastle Mater Misericordiae Hospital
 Contact Person Ph: 61-2-4985-0166
Tasmania
  Burnie
 North West Regional Hospital
 Contact Person Ph: 61-2-4985-0166
  Hobart
 Royal Hobart Hospital
 Contact Person Ph: 61-2-4985-0166
Victoria
  Box Hill
 Box Hill Hospital
 Contact Person Ph: 61-2-4985-0166
  East Melbourne
 Peter MacCallum Cancer Centre
 Contact Person Ph: 61-2-4985-0166
  East Ringwood
 Maroondah Hospital
 Contact Person Ph: 61-2-4985-0166
  Heidelberg
 Austin Health
 Contact Person Ph: 61-2-4985-0166
Austria
  Feldkirch-Tisis
 Landeskrankenhaus Feldkirch
 Contact Person Ph: 43-1-408-9230
  Graz
 Landeskrankenhaus/Universitatskliniken Graz
 Contact Person Ph: 43-1-408-9230
  Innsbruck
 Innsbruck Universitaetsklinik
 Contact Person Ph: 43-1-408-9230
  Linz
 Allgemeines Krankenhaus Linz
 Contact Person Ph: 43-1-408-9230
  Linz Donau
 Krankenhaus BHS Linz
 Contact Person Ph: 43-1-408-9230
  Salzburg
 St. Johanns-Spital
 Contact Person Ph: 43-1-408-9230
  Vienna
 Allgemeines Krankenhaus - Universitatskliniken
 Contact Person Ph: 43-1-408-9230
 Contact Person Ph: 43-1-408-9230
 Hanusch-Krankenhaus
 Contact Person Ph: 43-1-408-9230
 Krankenhaus Lainz
 Contact Person Ph: 43-1-408-9230
  Villach
 LKH Villach
 Contact Person Ph: 43-1-408-9230
  Wels
 Klinikum Kreuzschwestern Wels GmbH
 Contact Person Ph: 43-1-408-9230
Belgium
  Antwerpen
 Ziekenhuis Netwerk Antwerpen Middelheim
 Contact Person Ph: 32-3-280-3111
  Arlon
 Cliniques du Sud Luxembourg
 Contact Person Ph: 32-63-23-1111
  Bonheiden
 Imelda vzw, Ziekenhuis
 Contact Person Ph: 32-15-505-011
  Brasschaat
 AZ Klina
 Contact Person Ph: 32-3-650- 5050
  Brussels
 Academisch Ziekenhuis der Vrije Universiteit Brussel
 Contact Person Ph: 32-02-477-6147
 Centre Hospitalier Universitaire Brugmann
 Contact Person Ph: 32-2-477-21-11
 Cliniques Universitaires Saint-Luc
 Contact Person Ph: 32-2-764-1111
 Institut Jules Bordet
 Contact Person Ph: 32-2-541-3082
  Duffel
 Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg
 Contact Person Ph: 32-15-30-3111
  Ghent
 Universitair Ziekenhuis Gent
 Contact Person Ph: 32-9-240-2111
  Haine Saint Paul
 Hopital de Jolimont
 Contact Person Ph: 32-6-423-4180
  Hasselt
 Virga Jesse Hospital
 Contact Person Ph: 32-11-309-960
  Huy
 Centre Hospitalier Hutois
 Contact Person Ph: 32-85-27-21-11
  Kortrijk
 AZ Groeninge - Oncologisch Centrum
 Contact Person Ph: 32-56-234-305
  Leuven
 U.Z. Gasthuisberg
 Contact Person Ph: 32-16-34-46-34
  Libramont
 Centre Hospitalier de l'Ardenne
 Contact Person Ph: 32-61-238-790
  Liege
 Centre Hospitalier Regional de la Citadelle
 Contact Person Ph: 32-4-225-6111
 CHU Liege - Domaine Universitaire du Sart Tilman
 Contact Person Ph: 32-43-667-111
 Clinique Saint-Joseph
 Contact Person Ph: 32-4-224-8990
  Merksem
 Jan Palfijn Hospital
 Contact Person Ph: 32-3-640-2020
  Oostende
 AZ Damiaan
 Contact Person Ph: 32-59-553-404
  Ottignies
 Clinique Saint-Pierre
 Contact Person Ph: 32-10-437-211
  Rocourt
 Clinique Saint Vincent
 Contact Person Ph: 32-4-239-4703
  Sint-Niklaas
 AZ Nikolaas - Sint-Niklaas
 Contact Person Ph: 32-3-760-2985
  Turnhout
 Sint-Elisabethziekenhuis
 Contact Person Ph: 32-14-40-69-02
  Verviers
 Centre Hospitalier Peltzer-La Tourelle
 Contact Person Ph: 32-87-212-171
Chile
  Penalolen
 Hospital Santiago Oriente Dr. Luis Tisne Brousse
 Contact Person Ph: 56-2-235-7923
  Santiago
 Fundacion Arturo Lopez Perez
 Contact Person Ph: 56-2-235-7923
 Hospital Clinico San Borja Arriaran
 Contract Person Ph: 56-2-235-7923
 Instituto Nacional Del Cancer
 Contact Person Ph: 56-2-235-7923
 IRAM - Chile
 Contact Person Ph: 56-2-235-7923
  Valdivia
 Hospital Clinico Regional de Valdivia at University Austral de Chile
 Contact Person Ph: 56-2-235-7923
  Valparaiso
 Hospital Carlos Van Buren
 Contact Person Ph: 56-2-235-7923
Denmark
  Aarhus C
 Aarhus Universitetshospital - Aarhus Sygehus
 Contact Person Ph: 45-89-49-44-44
  Copenhagen
 Copenhagen County Herlev University Hospital
 Contact Person Ph: 45-44-884-488
  Esbjerg
 Centralsygehus Esbjerg
 Contact Person Ph: 45-7918-2000
  Herning
 Herning Central Hospital
 Contact Person Ph: +45 44 88 44 88
  Hillerod
 Hillerod Hospital
 Contact Person Ph: 45-4-829-6100
  Naestved
 Naestved Hospital
 Contact Person Ph: 45-5651-2000
  Odense
 Odense University Hospital
 Contact Person Ph: 45-6611-3333
  Ronne
 Bornholms Hospital
 Contact Person Ph: 45-5695-1165
  Roskilde
 Roskilde Amtssygehuset
 Contact Person Ph: 45-4632-3200
  Sonderborg
 Sonderborg Sygehus
 Contact Person Ph: +45 44 88 44 88
  Vejle
 Vejle Sygehus
 Contact Person Ph: +45 44 88 44 88
  Viborg
 Viborg Sygehus
 Contact Person Ph: +45 44 88 44 88
France
  Bordeaux
 Institut Bergonie
 Contact Person Ph: 33-5-5633-7817
Germany
  Aalen
 Aalen Breast Center
 Contact Person Ph: 49-6102-7480-449
  Bielefeld
 Onkologische Schwerpunktpraxis Bielefeld
 Contact Person Ph: 49-6102-7480-449
  Celle
 Allgemeinen Krankenhaus Celle Kinderklinik
 Contact Person Ph: 49-6102-7480-449
  Deggendorf
 Klinikum Deggendorf
 Contact Person Ph: 49-6102-7480-449
  Fuerth
 Praxis Dr. Wilke - Onkologie am Klinikum Fuerth
 Contact Person Ph: 49-6102-7480-449
  Hannover
 Gynaekologisch-onkologische Praxis Hannover
 Contact Person Ph: 49-6102-7480-449
 Henriettenstiftung Krankenhaus
 Contact Person Ph: 49-6102-7480-449
 Vinzenzkrankenhaus Hannover gGmbH
 Contact Person Ph: 49-6102-7480-449
  Ilsede
 Frauenheilkunde u. Geburtshilfe
 Contact Person Ph: 49-6102-7480-449
  Lich
 Asklepios Klinik Lich
 Contact Person Ph: 49-6102-7480-449
  Mannheim
 Gemeinschaftspraxis Gynaekologie & Geburtshilfe
 Contact Person Ph: 49-6102-7480-449
  Meiningen
 Klinikum Meiningen GmbH
 Contact Person Ph: 49-6102-7480-449
  Memmingen
 Klinikum Memmingen
 Contact Person Ph: 49-6102-7480-449
  Offenbach
 Klinikum Offenback GmbH
 Contact Person Ph: 49-6102-7480-449
  Schwabisch Hall
 Deaconess Hospital
 Contact Person Ph: 49-6102-7480-449
  Stendal
 Johanniter Kankenhaus Stendal
 Contact Person Ph: 49-6102-7480-449
  Suhl
 SRH Zentralklinikum Suhl GmbH
 Contact Person Ph: 49-6102-7480-449
  Tuebingen
 Universitaetsklinikum Tuebingen
 Contact Person Ph: 49-6102-7480-449
Hungary
  Budapest
 National Institute of Oncology - Budapest
 Contact Person Ph: 36-1-224-8763
  Szeged
 Szeged University
 Contact Person Ph: +36 1 22 48 763
India
  Mumbai
 Tata Memorial Hospital
 Contact Person Ph: 91-22-2417-7144
Italy
  Aviano
 Centro di Riferimento Oncologico - Aviano
 Contact Person Ph: 39-43-465-9653
  Biella
 Ospedale degli Infermi - ASL 12
 Contact Person Ph: 39-015-35-031
  Bolzano
 Azienda Sanitaria di Bolzano
 Contact Person Ph: 39-471-908-572
  Brescia
 Spedali Civili di Brescia
 Contact Person Ph: 39-030-395-823
  Brindisi
 A. Perrino Hospital
 Contact Person Ph: 39-0831-537-508
  Cremona
 Azienda Istituti Ospitalieri
 Contact Person Ph: 372-405111
  Meldola
 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
 Contact Person Ph: +39 025 748 99 34
  Milan
 European Institute of Oncology
 Contact Person Ph: 39-02-5748-9934
  Pavia
 Fondazione Salvatore Maugeri
 Contact Person Ph: 39-0382-592-504
  Prato
 Misericordia e Dolce Hospital
 Contact Person Ph: 39-0574-43-4766
  Rimini
 Ospedale Civile Rimini
 Contact Person Ph: 39-0541-705-567
  Varese
 Ospedale di Circolo e Fondazione Macchi
 Contact Person Ph: 39-332-278-376
Japan
  Kagoshima
 Sagara Hospital
 Contact Person Ph: 81-3-66659-7723
  Kumamoto
 Kumamoto University Faculty of Medical and Pharmaceutical Sciences
 Contact Person Ph: 81-3-66659-7723
  Kyoto
 Kyoto University Hospital
 Contact Person Ph: 81-3-66659-7723
  Niigata
 Niigata Cancer Center Hospital
 Contact Person Ph: 81-3-66659-7723
  Osaka
 Yao Municipal Hospital
 Contact Person Ph: 81-3-66659-7723
  Sakai
 Osaka Rosai Hospital
 Contact Person Ph: 81-3-66659-7723
  Tokyo
 Tokyo Metropolitan - Komagome Hospital
 Contact Person Ph: 81-3-66659-7723
New Zealand
  Hamilton
 Waikato Hospital
 Contact Person Ph: 61-2-4985-0166
Peru
  Lima
 Instituto Nacional de Enfermedades Neoplasicas
 Contact Person Ph: 511-710-6900
Republic of South Africa
  Sandton
 Sandton Oncology Medical Research
 Contact Person Ph: 27-11-883-0900-4
  Tygerberg
 Tygerberg Hospital
 Contact Person Ph: 27-21-938-9277
Russia
  Moscow
 Russian Academy of Medical Sciences Cancer Research Center
 Contact Person Ph: 7-903-597-7348
Spain
  Barcelona
 Vall d'Hebron University Hospital
 Contact Person Ph: 34-93-715-6400
  Madrid
 Hospital Ramon y Cajal
 Contact Person Ph: 34-93-715-6400
 Hospital Universitario 12 de Octubre
 Contact Person Ph: 34-93-715-6400
 M. D. Anderson International Espana SA
 Contact Person Ph: 34-93-715-6400
  Palma De Mallorca
 Hospital Son Llatzer
 Contact Person Ph: 34-93-715-6400
  Reus
 Hospital Sant Joan de Reus
 Contact Person Ph: 34-93-715-6400
  Sevilla
 Hospital Universitario Virgen Macarena
 Contact Person Ph: 34-93-715-6400
  Torrevieja
 Hospital de Torrevieja
 Contact Person Ph: 34-93-715-6400
  Valencia
 Hospital Clinico Universitario de Valencia
 Contact Person Ph: 34-93-715-6400
 Instituto Valenciano De Oncologia
 Contact Person Ph: 34-93-715-6400
Sweden
  Boras
 Lasarettet i Boras
 Contact Person Ph: 46-33-161-850
  Eskilstuna
 Malarsjukhuset Hospital
 Contact Person Ph: 46-73-822-8002
  Gothenburg
 Sahlgrenska University Hospital
 Contact Person Ph: 46-31-342-1000
  Lidkoping
 Lidkoping Hospital
 Contact Person Ph: +46 313 42 10 00
  Skovde
 Skaraborgs Hospital
 Contact Person Ph: 46-500-431-028
  Stockholm
 Karolinska University Hospital - Huddinge
 Contact Person Ph: 46-8-585-800-00
Switzerland
  Aarau
 Kantonsspital Aarau
 Contact Person Ph: 41-62-838-6050
  Baden
 Kantonsspital Baden
 Contact Person Ph: 41-56-842-111
  Bellinzona
 Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
 Contact Person Ph: 41-91-811-8666
  Bern
 Inselspital Bern
 Contact Person Ph: 41-31-632-4114
 Oncocare Sonnenhof-Klinik Engeriedspital
 Contact Person Ph: 41-31-309-9501
  Cham
 AndreasKlinik Cham Zug
 Contact Person Ph: 41-41-784-0784
  Chur
 Kantonsspital Graubuenden
 Contact Person Ph: 41-81-256-6111
  Frauenfeld
 Brustzentrum Thurgau at Kantonsspital Frauenfeld
 Contact Person Ph: 41-52-723-7711
  Freiburg
 Kantonsspital Freiburg
 Contact Person Ph: 41-26-426-7111
  Lausanne
 Centre Hospitalier Universitaire Vaudois
 Contact Person Ph: 41-21-314-0150
  Locarno
 Lago Maggiore Oncology Foundation
 Contact Person Ph: 41-91-751-8230
 Ospedale "la Carita", Locarno
 Contact Person Ph: 41-91-310-121
  Lugano
 Ospedale Civico
 Contact Person Ph: 41-91-811-6111
  Mendrisio
 Ospedale Beata Vergine
 Contact Person Ph: 41-91-811-3395
  Olten
 Kantonsspital Olten
 Contact Person Ph: 41-62-311-4111
  Sion
 Hopital Regional de Sion-Herens-Conthey
 Contact Person Ph: 41-27-603-4000
  St. Gallen
 Kantonsspital - St. Gallen
 Contact Person Ph: 41-71-494-1062
 Tumor Zentrum ZeTup St. Gallen und Chur
 Contact Person Ph: 41-71-243-0043
  Thun
 Regionalspital
 Contact Person Ph: 41-33-226-2645
  Winterthur
 Kantonsspital Winterthur
 Contact Person Ph: +41 31 632 41 14
  Zurich
 Breast Center
 Contact Person Ph: 41-44-380-7660
 City Hospital Triemli
 Contact Person Ph: 41-1-466-1111
 UniversitaetsSpital Zuerich
 Contact Person Ph: 41-44-255-1111
United Kingdom
England
  Melrose
 Borders General Hospital
 Contact Person Ph: 44-131-275-6544
Scotland
  Dumfries
 Dumfries & Galloway Royal Infirmary
 Contact Person Ph: 44-131-275-6544

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00553410
Information obtained from ClinicalTrials.gov on March 04, 2012

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top