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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)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Letrozole
Letrozole
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  • Faulkner Hospital
  • Armidale Hospital
  • Bankstown - Lidcombe Hospital
  • Southern Highlands Cancer Center
  • Concord Repatriation General Hospital
  • Breast Center
  • Port Mcquarie Base Hospital
  • Prince of Wales Private Hospital
  • Tamworth Base Hospital
  • Tweed Heads Hospital
  • Calvary Mater Newcastle
  • North West Regional Hospital
  • Royal Hobart Hospital
  • Box Hill Hospital
  • Peter MacCallum Cancer Centre
  • Austin Health
  • Maroondah Hospital
  • Royal Perth Hospital
  • Landeskrankenhaus Feldkirch
  • Medizinische Universitaet Graz
  • Innsbruck Universitaetsklinik
  • Krankenhaus BHS Linz
  • Allgemeines Krankenhaus Linz
  • St. Johanns-Spital
  • Medical University of Vienna
  • Allgemeines Krankenhaus - Universitatskliniken
  • Krankenhaus Lainz
  • Hanusch-Krankenhaus
  • LKH Villach
  • Klinikum Kreuzschwestern Wels GmbH
  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Cliniques du Sud Luxembourg
  • Imelda vzw, Ziekenhuis
  • AZ Klina
  • Institut Jules Bordet
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Cliniques Universitaires Saint-Luc
  • Centre Hospitalier Universitaire Brugmann
  • Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg
  • Universitair Ziekenhuis Gent
  • Hopital de Jolimont
  • Virga Jesse Hospital
  • Centre Hospitalier Hutois
  • AZ Groeninge - Oncologisch Centrum
  • U.Z. Gasthuisberg
  • Centre Hospitalier de l'Ardenne
  • Centre Hospitalier Regional de la Citadelle
  • Clinique Saint-Joseph
  • CHU Liege - Domaine Universitaire du Sart Tilman
  • Jan Palfijn Hospital
  • AZ Damiaan
  • Clinique Saint-Pierre
  • Clinique Saint Vincent
  • AZ Nikolaas - Sint-Niklaas
  • Sint-Elisabethziekenhuis
  • Centre Hospitalier Peltzer-La Tourelle
  • Hospital Santiago Oriente Dr. Luis Tisne Brousse
  • Fundacion Arturo Lopez Perez
  • Hospital Clinico San Borja Arriaran
  • Instituto Nacional Del Cancer
  • IRAM - Chile
  • Hospital Clinico Regional de Valdivia at University Austral de Chile
  • Hospital Carlos Van Buren
  • Aarhus Universitetshospital - Aarhus Sygehus
  • Copenhagen County Herlev University Hospital
  • Centralsygehus Esbjerg
  • Herning Central Hospital
  • Hillerod Hospital
  • Naestved Hospital
  • Odense University Hospital
  • Bornholms Hospital
  • Roskilde Amtssygehuset
  • Sonderborg Sygehus
  • Vejle Sygehus
  • Viborg Sygehus
  • Institut Bergonie
  • Aalen Breast Center
  • Onkologische Schwerpunktpraxis Bielefeld
  • Allgemeinen Krankenhaus Celle Kinderklinik
  • Klinikum Deggendorf
  • Praxis Dr. Wilke - Onkologie am Klinikum Fuerth
  • Vinzenzkrankenhaus Hannover gGmbH
  • Henriettenstiftung Krankenhaus
  • Gynaekologisch-onkologische Praxis Hannover
  • Frauenheilkunde u. Geburtshilfe
  • Asklepios Klinik Lich
  • Gemeinschaftspraxis Gynaekologie & Geburtshilfe
  • Klinikum Meiningen GmbH
  • Klinikum Memmingen
  • Klinikum Offenback GmbH
  • Deaconess Hospital
  • Johanniter Kankenhaus Stendal
  • SRH Zentralklinikum Suhl GmbH
  • Universitaetsklinikum Tuebingen
  • National Institute of Oncology - Budapest
  • Szeged University
  • Tata Memorial Hospital
  • Centro di Riferimento Oncologico - Aviano
  • Ospedale degli Infermi - ASL 12
  • Azienda Sanitaria di Bolzano
  • Spedali Civili di Brescia
  • A. Perrino Hospital
  • Azienda Istituti Ospitalieri
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • European Institute of Oncology
  • Fondazione Salvatore Maugeri
  • Misericordia e Dolce Hospital
  • Ospedale Civile Rimini
  • Ospedale di Circolo e Fondazione Macchi
  • Osaka Rosai Hospital
  • Sagara Hospital
  • Kumamoto University Faculty of Medical and Pharmaceutical Sciences
  • Kyoto University Hospital
  • Niigata Cancer Center Hospital
  • Yao Municipal Hospital
  • Tokyo Metropolitan - Komagome Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • Instituto Nacional de Enfermedades Neoplasicas
  • Russian Academy of Medical Sciences Cancer Research Center
  • Tygerberg Hospital
  • Sandton Oncology Medical Research
  • Vall d'Hebron University Hospital
  • M. D. Anderson International Espana SA
  • Hospital Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Son Llatzer
  • Hospital Sant Joan de Reus
  • Hospital Universitario Virgen Macarena
  • Hospital de Torrevieja
  • Instituto Valenciano De Oncologia
  • Hospital Clinico Universitario de Valencia
  • Lasarettet i Boras
  • Malarsjukhuset Hospital
  • Sahlgrenska University Hospital
  • Lidkoping Hospital
  • Skaraborgs Hospital
  • Karolinska University Hospital - Huddinge
  • Kantonsspital Aarau
  • Kantonsspital Baden
  • Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
  • Inselspital Bern
  • Oncocare Sonnenhof-Klinik Engeriedspital
  • AndreasKlinik Cham Zug
  • Kantonsspital Graubuenden
  • Brustzentrum Thurgau at Kantonsspital Frauenfeld
  • Kantonsspital Freiburg
  • Centre Hospitalier Universitaire Vaudois
  • Lago Maggiore Oncology Foundation
  • Ospedale "la Carita", Locarno
  • Ospedale Civico
  • Ospedale Beata Vergine
  • Kantonsspital Olten
  • Hopital Regional de Sion-Herens-Conthey
  • Tumor Zentrum ZeTup St. Gallen und Chur
  • Kantonsspital - St. Gallen
  • Regionalspital
  • Kantonsspital Winterthur
  • Breast Center
  • City Hospital Triemli
  • UniversitaetsSpital Zuerich
  • Borders General Hospital
  • Dumfries & Galloway Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous letrozole

Intermittent letrozole

Arm Description

Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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
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.

Full Information

First Posted
November 2, 2007
Last Updated
March 9, 2020
Sponsor
ETOP IBCSG Partners Foundation
Collaborators
Breast International Group
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1. Study Identification

Unique Protocol Identification Number
NCT00553410
Brief Title
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
Acronym
SOLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation
Collaborators
Breast International Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4884 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous letrozole
Arm Type
Active Comparator
Arm Description
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)
Arm Title
Intermittent letrozole
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
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
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
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.
Time Frame
5-year estimates, reported at a median follow-up of 60 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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).
Time Frame
5-year estimates, reported at a median follow-up of 60 months
Title
Distant Recurrence-free Interval (DRFI)
Description
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
Time Frame
5-year estimates, reported at a median follow-up of 60 months
Title
Breast Cancer-free Interval
Description
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.
Time Frame
5-year estimates, reported at a median follow-up of 60 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33082214
Citation
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.
Results Reference
derived
PubMed Identifier
29158011
Citation
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.
Results Reference
derived

Learn more about this trial

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

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