Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT00553410

PHASE3

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

Sponsor: ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

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.

Official title: SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

4884

Start Date

2007-08

Completion Date

2019-05-15

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

Letrozole

Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously

DRUG

Letrozole

Film-coated tablet, oral use, 2.5 mg daily, 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

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

Locations (164)

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Faulkner Hospital

Boston, Massachusetts, United States

Armidale Hospital

Armidale, New South Wales, Australia

Bankstown - Lidcombe Hospital

Bankstown, New South Wales, Australia

Southern Highlands Cancer Center

Bowral, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Breast Center

Gateshead, 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

Royal Hobart Hospital

Hobart, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Maroondah Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Medizinische Universitaet Graz

Graz, Austria

Innsbruck Universitaetsklinik

Innsbruck, Austria

Krankenhaus BHS Linz

Linz, Austria

Allgemeines Krankenhaus Linz

Linz, Austria

St. Johanns-Spital

Salzburg, Austria

Medical University of Vienna

Vienna, Austria

Allgemeines Krankenhaus - Universitatskliniken

Vienna, Austria

Krankenhaus Lainz

Vienna, Austria

Hanusch-Krankenhaus

Vienna, Austria

LKH Villach

Villach, Austria

Klinikum Kreuzschwestern Wels GmbH

Wels, Austria

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, Belgium

Cliniques du Sud Luxembourg

Arlon, Belgium

Imelda vzw, Ziekenhuis

Bonheiden, Belgium

AZ Klina

Brasschaat, Belgium

Institut Jules Bordet

Brussels, Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Hospitalier Universitaire Brugmann

Brussels, Belgium

Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg

Duffel, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Hopital de Jolimont

Haine-Saint-Paul, Belgium

Virga Jesse Hospital

Hasselt, Belgium

Centre Hospitalier Hutois

Huy, Belgium

AZ Groeninge - Oncologisch Centrum

Kortrijk, Belgium

U.Z. Gasthuisberg

Leuven, Belgium

Centre Hospitalier de l'Ardenne

Libramont, Belgium

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Clinique Saint-Joseph

Liège, Belgium

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, Belgium

Jan Palfijn Hospital

Merksem, Belgium

AZ Damiaan

Ostend, Belgium

Clinique Saint-Pierre

Ottignies, Belgium

Clinique Saint Vincent

Rocourt, Belgium

AZ Nikolaas - Sint-Niklaas

Sint-Niklaas, Belgium

Sint-Elisabethziekenhuis

Turnhout, Belgium

Centre Hospitalier Peltzer-La Tourelle

Verviers, Belgium

Hospital Santiago Oriente Dr. Luis Tisne Brousse

Peñalolén, Chile

Fundacion Arturo Lopez Perez

Santiago, Chile

Hospital Clinico San Borja Arriaran

Santiago, Chile

Instituto Nacional Del Cancer

Santiago, Chile

IRAM - Chile

Santiago, Chile

Hospital Clinico Regional de Valdivia at University Austral de Chile

Valdivia, Chile

Hospital Carlos Van Buren

Valparaíso, Chile

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus C, Denmark

Copenhagen County Herlev University Hospital

Copenhagen, Denmark

Centralsygehus Esbjerg

Esbjerg, Denmark

Herning Central Hospital

Herning, Denmark

Hillerod Hospital

Hillerød, Denmark

Naestved Hospital

Næstved, Denmark

Odense University Hospital

Odense, Denmark

Roskilde Amtssygehuset

Roskilde, Denmark

Bornholms Hospital

Rønne, Denmark

Sonderborg Sygehus

Sønderborg, Denmark

Vejle Sygehus

Vejle, Denmark

Viborg Sygehus

Viborg, Denmark

Institut Bergonie

Bordeaux, France

Aalen Breast Center

Aalen, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Allgemeinen Krankenhaus Celle Kinderklinik

Celle, Germany

Klinikum Deggendorf

Deggendorf, Germany

Praxis Dr. Wilke - Onkologie am Klinikum Fuerth

Fürth, Germany

Vinzenzkrankenhaus Hannover gGmbH

Hanover, Germany

Henriettenstiftung Krankenhaus

Hanover, Germany

Gynaekologisch-onkologische Praxis Hannover

Hanover, Germany

Frauenheilkunde u. Geburtshilfe

Ilsede, Germany

Asklepios Klinik Lich

Lich, Germany

Gemeinschaftspraxis Gynaekologie & Geburtshilfe

Mannheim, Germany

Klinikum Meiningen GmbH

Meiningen, Germany

Klinikum Memmingen

Memmingen, Germany

Klinikum Offenback GmbH

Offenbach, Germany

Deaconess Hospital

Schwäbisch Hall, Germany

Johanniter Kankenhaus Stendal

Stendal, Germany

SRH Zentralklinikum Suhl GmbH

Suhl, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

National Institute of Oncology - Budapest

Budapest, Hungary

Szeged University

Szeged, Hungary

Tata Memorial Hospital

Mumbai, India

Centro di Riferimento Oncologico - Aviano

Aviano, Italy

Ospedale degli Infermi - ASL 12

Biella, Italy

And 64 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (164)