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 (SOLE)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Letrozole; Drug: Letrozole

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.

• Study Type: Interventional
• Enrollment (Actual): 4884
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Armidale, New South Wales, Australia, 2350
      • Armidale Hospital
    • Bankstown, New South Wales, Australia, 2200
      • Bankstown - Lidcombe Hospital
    • Bowral, New South Wales, Australia, 2576
      • Southern Highlands Cancer Center
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Gateshead, New South Wales, Australia, 2290
      • Breast Center
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Mcquarie Base Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Private Hospital
    • Tamworth, New South Wales, Australia, 2340
      • Tamworth Base Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • Tweed Heads Hospital
    • Waratah, New South Wales, Australia, 2310
      • Calvary Mater Newcastle
  • Tasmania
    • Burnie, Tasmania, Australia, 7320
      • North West Regional Hospital
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Melbourne, Victoria, Australia, 3135
      • Maroondah Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Austria
  • Feldkirch, Austria, A-6807
    • Landeskrankenhaus Feldkirch
  • Graz, Austria, A-8036
    • Medizinische Universitaet Graz
  • Innsbruck, Austria, A-6020
    • Innsbruck Universitaetsklinik
  • Linz, Austria, A-4010
    • Krankenhaus BHS Linz
  • Linz, Austria, A-4021
    • Allgemeines Krankenhaus Linz
  • Salzburg, Austria, A-5020
    • St. Johanns-Spital
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, A-1140
    • Hanusch-Krankenhaus
  • Vienna, Austria, A-1090
    • Allgemeines Krankenhaus - Universitatskliniken
  • Vienna, Austria, A-1130
    • Krankenhaus Lainz
  • Villach, Austria, 9500
    • LKH Villach
  • Wels, Austria, 4600
    • Klinikum Kreuzschwestern Wels GmbH
• Belgium
  • Antwerpen, Belgium, B-2020
    • Ziekenhuis Netwerk Antwerpen Middelheim
  • Arlon, Belgium, 6700
    • Cliniques du Sud Luxembourg
  • Bonheiden, Belgium, 2820
    • Imelda vzw, Ziekenhuis
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Brussels, Belgium, 1090
    • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Brussels, Belgium, B 1020
    • Centre Hospitalier Universitaire Brugmann
  • Duffel, Belgium, 2570
    • Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg
  • Ghent, Belgium, B-9000
    • Universitair Ziekenhuis Gent
  • Haine Saint Paul, Belgium, 7100
    • Hôpital de Jolimont
  • Hasselt, Belgium, 3500
    • Virga Jesse Hospital
  • Huy, Belgium, 4500
    • Centre Hospitalier Hutois
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Oncologisch Centrum
  • Leuven, Belgium, B-3000
    • U.Z. Gasthuisberg
  • Libramont, Belgium, 6800
    • Centre Hospitalier de l'Ardenne
  • Liege, Belgium, B-4000
    • CHU Liege - Domaine Universitaire du Sart Tilman
  • Liege, Belgium, B 4000
    • Clinique Saint-Joseph
  • Liege, Belgium, 4000
    • Centre Hospitalier Regional de la Citadelle
  • Merksem, Belgium, B-2170
    • Jan Palfijn Hospital
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Ottignies, Belgium, B-1340
    • Clinique Saint-Pierre
  • Rocourt, Belgium, 4000
    • Clinique Saint Vincent
  • Sint-Niklaas, Belgium, 9100
    • AZ Nikolaas - Sint-Niklaas
  • Turnhout, Belgium, 2300
    • Sint-Elisabethziekenhuis
  • Verviers, Belgium, B-4800
    • Centre Hospitalier Peltzer-La Tourelle
• Chile
  • Penalolen, Chile, 2005
    • Hospital Santiago Oriente Dr. Luis Tisne Brousse
  • Santiago, Chile
    • Instituto Nacional del Cancer
  • Santiago, Chile
    • Hospital Clinico San Borja Arriarán
  • Santiago, Chile, 29
    • Fundación Arturo López Pérez
  • Santiago, Chile
    • IRAM - Chile
  • Valdivia, Chile
    • Hospital Clinico Regional de Valdivia at University Austral de Chile
  • Valparaiso, Chile
    • Hospital Carlos Van Buren
• Denmark
  • Aarhus C, Denmark, DK-8000
    • Aarhus Universitetshospital - Aarhus Sygehus
  • Copenhagen, Denmark, DK-2730
    • Copenhagen County Herlev University Hospital
  • Esbjerg, Denmark, DK-6700
    • Centralsygehus Esbjerg
  • Herning, Denmark, DK-7400
    • Herning Central Hospital
  • Hillerod, Denmark, 3400
    • Hillerod Hospital
  • Naestved, Denmark, 4700
    • Naestved Hospital
  • Odense, Denmark, DK-5000
    • Odense University Hospital
  • Ronne, Denmark, 3700
    • Bornholms Hospital
  • Roskilde, Denmark, 4000
    • Roskilde Amtssygehuset
  • Sonderborg, Denmark, 6400
    • Sonderborg Sygehus
  • Vejle, Denmark, DK-7100
    • Vejle Sygehus
  • Viborg, Denmark, 8800
    • Viborg Sygehus
• France
  • Bordeaux, France, 33076
    • Institut Bergonie
• Germany
  • Aalen, Germany, 73430
    • Aalen Breast Center
  • Bielefeld, Germany, D-33602
    • Onkologische Schwerpunktpraxis Bielefeld
  • Celle, Germany, 29223
    • Allgemeinen Krankenhaus Celle Kinderklinik
  • Deggendorf, Germany, 94469
    • Klinikum Deggendorf
  • Fuerth, Germany, 90766
    • Praxis Dr. Wilke - Onkologie am Klinikum Fuerth
  • Hannover, Germany, 30559
    • Vinzenzkrankenhaus Hannover gGmbH
  • Hannover, Germany, D-30171
    • Henriettenstiftung Krankenhaus
  • Hannover, Germany, D-30177
    • Gynaekologisch-onkologische Praxis Hannover
  • Ilsede, Germany, 31241
    • Frauenheilkunde u. Geburtshilfe
  • Lich, Germany, D-35423
    • Asklepios Klinik Lich
  • Mannheim, Germany, D68161
    • Gemeinschaftspraxis Gynaekologie & Geburtshilfe
  • Meiningen, Germany, 98617
    • Klinikum Meiningen GmbH
  • Memmingen, Germany, 87700
    • Klinikum Memmingen
  • Offenbach, Germany, D-63069
    • Klinikum Offenback GmbH
  • Schwabisch Hall, Germany, D-74523
    • Deaconess Hospital
  • Stendal, Germany, 39576
    • Johanniter Kankenhaus Stendal
  • Suhl, Germany, 98527
    • SRH Zentralklinikum Suhl GmbH
  • Tuebingen, Germany, D-72076
    • Universitaetsklinikum Tuebingen
• Hungary
  • Budapest, Hungary, 1122
    • National Institute of Oncology - Budapest
  • Szeged, Hungary, H-6720
    • Szeged University
• India
  • Mumbai, India, 400012
    • Tata Memorial Hospital
• Italy
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico - Aviano
  • Biella, Italy, 13900
    • Ospedale degli Infermi - ASL 12
  • Bolzano, Italy, 39100
    • Azienda Sanitaria di Bolzano
  • Brescia, Italy, 25123
    • Spedali Civili di Brescia
  • Brindisi, Italy, 72100
    • A. Perrino Hospital
  • Cremona, Italy, 26100
    • Azienda Istituti Ospitalieri
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20141
    • European Institute of Oncology
  • Pavia, Italy, I-27100
    • Fondazione Salvatore Maugeri
  • Prato, Italy, 59100
    • Misericordia e Dolce Hospital
  • Rimini, Italy, 47900
    • Ospedale Civile Rimini
  • Varese, Italy, 21100
    • Ospedale Di Circolo E Fondazione Macchi
• Japan
  • Kagoshima, Japan
    • Sagara Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Faculty of Medical and Pharmaceutical Sciences
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 581-0069
    • Yao Municipal Hospital
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan - Komagome Hospital
  • Osaka
    • Sakai, Osaka, Japan, 1179-3
      • Osaka Rosai Hospital
• New Zealand
  • Christchurch, New Zealand, 1
    • Christchurch Hospital
  • Hamilton, New Zealand, 2020
    • Waikato Hospital
• Peru
  • Lima, Peru, 34
    • Instituto Nacional de Enfermedades Neoplasicas
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Russian Academy of Medical Sciences Cancer Research Center
• South Africa
  • Kapstadt, South Africa, 7505
    • Tygerberg Hospital
  • Sandton, South Africa, 2199
    • Sandton Oncology Medical Research
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebrón University Hospital
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28033
    • M. D. Anderson International Espana SA
  • Palma De Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Reus, Spain, 43201
    • Hospital Sant Joan de Reus
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Torrevieja, Spain, 03180
    • Hospital de Torrevieja
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46009
    • Instituto Valenciano De Oncologia
• Sweden
  • Boras, Sweden, 501 15
    • Lasarettet i Boras
  • Eskilstuna, Sweden
    • Mälarsjukhuset Hospital
  • Gothenburg, Sweden, S-413 45
    • Sahlgrenska University Hospital
  • Lidkoping, Sweden, S-53185
    • Lidkoping Hospital
  • Skovde, Sweden, 541 85
    • Skaraborgs Hospital
  • Stockholm, Sweden, S-141 86
    • Karolinska University Hospital - Huddinge
• Switzerland
  • Aarau, Switzerland, CH-5001
    • Kantonsspital Aarau
  • Baden, Switzerland, CH-5404
    • Kantonsspital Baden
  • Bellinzona, Switzerland, CH-6500
    • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
  • Bern, Switzerland, CH-3010
    • Inselspital Bern
  • Bern, Switzerland, CH-3012
    • Oncocare Sonnenhof-Klinik Engeriedspital
  • Cham, Switzerland, CH-6330
    • AndreasKlinik Cham Zug
  • Chur, Switzerland, CH-7000
    • Kantonsspital Graubuenden
  • Frauenfeld, Switzerland, 8501
    • Brustzentrum Thurgau at Kantonsspital Frauenfeld
  • Freiburg, Switzerland, 1708
    • Kantonsspital Freiburg
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois
  • Locarno, Switzerland, 6600
    • Ospedale "la Carita", Locarno
  • Locarno, Switzerland, 6600
    • Lago Maggiore Oncology Foundation
  • Lugano, Switzerland, CH-6903
    • Ospedale Civico
  • Mendrisio, Switzerland, CH-6850
    • Ospedale Beata Vergine
  • Olten, Switzerland, CH-4600
    • Kantonsspital Olten
  • Sion, Switzerland, CH -1951
    • Hopital Regional de Sion-Herens-Conthey
  • St. Gallen, Switzerland, CH-9007
    • Kantonsspital - St. Gallen
  • St. Gallen, Switzerland, CH-9006
    • Tumor Zentrum ZeTup St. Gallen und Chur
  • Thun, Switzerland, 3600
    • Regionalspital
  • Winterthur, Switzerland, CH-8400
    • Kantonsspital Winterthur
  • Zurich, Switzerland, CH-8008
    • Breast Center
  • Zurich, Switzerland, CH-8063
    • City Hospital Triemli
  • Zurich, Switzerland, CH-8091
    • UniversitaetsSpital Zuerich
• United Kingdom
  • England
    • Melrose, England, United Kingdom, TD6 9BS
      • Borders General Hospital
  • Scotland
    • Dumfries, Scotland, United Kingdom, DG1 4AP
      • Dumfries & Galloway Royal Infirmary
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02130-3400
      • Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Continuous letrozole; Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)	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
EXPERIMENTAL: Intermittent 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	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.	5-year estimates, reported at a median follow-up of 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	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).	5-year estimates, reported at a median follow-up of 60 months
Distant Recurrence-free Interval (DRFI)	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	5-year estimates, reported at a median follow-up of 60 months
Breast Cancer-free Interval	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.	5-year estimates, reported at a median follow-up of 60 months

Collaborators and Investigators

• Sponsor: ETOP IBCSG Partners Foundation
• Collaborators: Breast International Group
• Investigators: Study Chair: Marco Colleoni, MD, European Institute of Oncology

Publications and helpful links

General Publications

• Guerini-Rocco E, Gray KP, Fumagalli C, Reforgiato MR, Leone I, Rafaniello Raviele P, Munzone E, Kammler R, Neven P, Hitre E, Jerusalem G, Simoncini E, Gombos A, Deleu I, Karlsson P, Aebi S, Chirgwin J, Di Lauro V, Thompson A, Graas MP, Barber M, Fontaine C, Loibl S, Gavila J, Kuroi K, Muller B, O'Reilly S, Di Leo A, Goldhirsch A, Viale G, Barberis M, Regan MM, Colleoni M. Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 Jan 15;27(2):504-512. doi: 10.1158/1078-0432.CCR-20-0126. Epub 2020 Oct 20.
• Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavila J, Kuroi K, Marth C, Muller B, O'Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):127-138. doi: 10.1016/S1470-2045(17)30715-5. Epub 2017 Nov 17.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): May 15, 2019

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 2, 2007
• First Posted (ESTIMATE): November 4, 2007

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage II breast cancer; stage IA breast cancer; stage IB breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: IBCSG 35-07 / BIG 1-07; 2007-001370-88 (EudraCT Number); CDR0000574249 (REGISTRY: CT.gov)