Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00553410




Registration number
NCT00553410
Ethics application status
Date submitted
2/11/2007
Date registered
4/11/2007
Date last updated
11/03/2020

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2007-001370-88
Secondary ID [2] 0 0
IBCSG 35-07 / BIG 1-07
Universal Trial Number (UTN)
Trial acronym
SOLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Letrozole
Treatment: Drugs - Letrozole

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

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


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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS)
Timepoint [1] 0 0
5-year estimates, reported at a median follow-up of 60 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
5-year estimates, reported at a median follow-up of 60 months
Secondary outcome [2] 0 0
Distant Recurrence-free Interval (DRFI)
Timepoint [2] 0 0
5-year estimates, reported at a median follow-up of 60 months
Secondary outcome [3] 0 0
Breast Cancer-free Interval
Timepoint [3] 0 0
5-year estimates, reported at a median follow-up of 60 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2019
Sample size
Target
Accrual to date
Final
4884
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
Recruitment hospital [1] 0 0
Armidale Hospital - Armidale
Recruitment hospital [2] 0 0
Bankstown - Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Southern Highlands Cancer Center - Bowral
Recruitment hospital [4] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
Breast Center - Gateshead
Recruitment hospital [6] 0 0
Port Mcquarie Base Hospital - Port Macquarie
Recruitment hospital [7] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [8] 0 0
Tamworth Base Hospital - Tamworth
Recruitment hospital [9] 0 0
Tweed Heads Hospital - Tweed Heads
Recruitment hospital [10] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [11] 0 0
North West Regional Hospital - Burnie
Recruitment hospital [12] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [15] 0 0
Austin Health - Heidelberg
Recruitment hospital [16] 0 0
Maroondah Hospital - Melbourne
Recruitment hospital [17] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2350 - Armidale
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2576 - Bowral
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
2290 - Gateshead
Recruitment postcode(s) [6] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [7] 0 0
2031 - Randwick
Recruitment postcode(s) [8] 0 0
2340 - Tamworth
Recruitment postcode(s) [9] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [10] 0 0
2310 - Waratah
Recruitment postcode(s) [11] 0 0
7320 - Burnie
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3002 - East Melbourne
Recruitment postcode(s) [15] 0 0
3084 - Heidelberg
Recruitment postcode(s) [16] 0 0
3135 - Melbourne
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Austria
State/province [2] 0 0
Feldkirch
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Austria
State/province [8] 0 0
Villach
Country [9] 0 0
Austria
State/province [9] 0 0
Wels
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Arlon
Country [12] 0 0
Belgium
State/province [12] 0 0
Bonheiden
Country [13] 0 0
Belgium
State/province [13] 0 0
Brasschaat
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Duffel
Country [16] 0 0
Belgium
State/province [16] 0 0
Ghent
Country [17] 0 0
Belgium
State/province [17] 0 0
Haine Saint Paul
Country [18] 0 0
Belgium
State/province [18] 0 0
Hasselt
Country [19] 0 0
Belgium
State/province [19] 0 0
Huy
Country [20] 0 0
Belgium
State/province [20] 0 0
Kortrijk
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Belgium
State/province [22] 0 0
Libramont
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Belgium
State/province [24] 0 0
Merksem
Country [25] 0 0
Belgium
State/province [25] 0 0
Oostende
Country [26] 0 0
Belgium
State/province [26] 0 0
Ottignies
Country [27] 0 0
Belgium
State/province [27] 0 0
Rocourt
Country [28] 0 0
Belgium
State/province [28] 0 0
Sint-Niklaas
Country [29] 0 0
Belgium
State/province [29] 0 0
Turnhout
Country [30] 0 0
Belgium
State/province [30] 0 0
Verviers
Country [31] 0 0
Chile
State/province [31] 0 0
Penalolen
Country [32] 0 0
Chile
State/province [32] 0 0
Santiago
Country [33] 0 0
Chile
State/province [33] 0 0
Valdivia
Country [34] 0 0
Chile
State/province [34] 0 0
Valparaiso
Country [35] 0 0
Denmark
State/province [35] 0 0
Aarhus C
Country [36] 0 0
Denmark
State/province [36] 0 0
Copenhagen
Country [37] 0 0
Denmark
State/province [37] 0 0
Esbjerg
Country [38] 0 0
Denmark
State/province [38] 0 0
Herning
Country [39] 0 0
Denmark
State/province [39] 0 0
Hillerod
Country [40] 0 0
Denmark
State/province [40] 0 0
Naestved
Country [41] 0 0
Denmark
State/province [41] 0 0
Odense
Country [42] 0 0
Denmark
State/province [42] 0 0
Ronne
Country [43] 0 0
Denmark
State/province [43] 0 0
Roskilde
Country [44] 0 0
Denmark
State/province [44] 0 0
Sonderborg
Country [45] 0 0
Denmark
State/province [45] 0 0
Vejle
Country [46] 0 0
Denmark
State/province [46] 0 0
Viborg
Country [47] 0 0
France
State/province [47] 0 0
Bordeaux
Country [48] 0 0
Germany
State/province [48] 0 0
Aalen
Country [49] 0 0
Germany
State/province [49] 0 0
Bielefeld
Country [50] 0 0
Germany
State/province [50] 0 0
Celle
Country [51] 0 0
Germany
State/province [51] 0 0
Deggendorf
Country [52] 0 0
Germany
State/province [52] 0 0
Fuerth
Country [53] 0 0
Germany
State/province [53] 0 0
Hannover
Country [54] 0 0
Germany
State/province [54] 0 0
Ilsede
Country [55] 0 0
Germany
State/province [55] 0 0
Lich
Country [56] 0 0
Germany
State/province [56] 0 0
Mannheim
Country [57] 0 0
Germany
State/province [57] 0 0
Meiningen
Country [58] 0 0
Germany
State/province [58] 0 0
Memmingen
Country [59] 0 0
Germany
State/province [59] 0 0
Offenbach
Country [60] 0 0
Germany
State/province [60] 0 0
Schwabisch Hall
Country [61] 0 0
Germany
State/province [61] 0 0
Stendal
Country [62] 0 0
Germany
State/province [62] 0 0
Suhl
Country [63] 0 0
Germany
State/province [63] 0 0
Tuebingen
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Hungary
State/province [65] 0 0
Szeged
Country [66] 0 0
India
State/province [66] 0 0
Mumbai
Country [67] 0 0
Italy
State/province [67] 0 0
Aviano
Country [68] 0 0
Italy
State/province [68] 0 0
Biella
Country [69] 0 0
Italy
State/province [69] 0 0
Bolzano
Country [70] 0 0
Italy
State/province [70] 0 0
Brescia
Country [71] 0 0
Italy
State/province [71] 0 0
Brindisi
Country [72] 0 0
Italy
State/province [72] 0 0
Cremona
Country [73] 0 0
Italy
State/province [73] 0 0
Meldola
Country [74] 0 0
Italy
State/province [74] 0 0
Milan
Country [75] 0 0
Italy
State/province [75] 0 0
Pavia
Country [76] 0 0
Italy
State/province [76] 0 0
Prato
Country [77] 0 0
Italy
State/province [77] 0 0
Rimini
Country [78] 0 0
Italy
State/province [78] 0 0
Varese
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka
Country [80] 0 0
Japan
State/province [80] 0 0
Kagoshima
Country [81] 0 0
Japan
State/province [81] 0 0
Kumamoto
Country [82] 0 0
Japan
State/province [82] 0 0
Kyoto
Country [83] 0 0
Japan
State/province [83] 0 0
Niigata
Country [84] 0 0
Japan
State/province [84] 0 0
Tokyo
Country [85] 0 0
New Zealand
State/province [85] 0 0
Christchurch
Country [86] 0 0
New Zealand
State/province [86] 0 0
Hamilton
Country [87] 0 0
Peru
State/province [87] 0 0
Lima
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Moscow
Country [89] 0 0
South Africa
State/province [89] 0 0
Kapstadt
Country [90] 0 0
South Africa
State/province [90] 0 0
Sandton
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Madrid
Country [93] 0 0
Spain
State/province [93] 0 0
Palma De Mallorca
Country [94] 0 0
Spain
State/province [94] 0 0
Reus
Country [95] 0 0
Spain
State/province [95] 0 0
Sevilla
Country [96] 0 0
Spain
State/province [96] 0 0
Torrevieja
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
Sweden
State/province [98] 0 0
Boras
Country [99] 0 0
Sweden
State/province [99] 0 0
Eskilstuna
Country [100] 0 0
Sweden
State/province [100] 0 0
Gothenburg
Country [101] 0 0
Sweden
State/province [101] 0 0
Lidkoping
Country [102] 0 0
Sweden
State/province [102] 0 0
Skovde
Country [103] 0 0
Sweden
State/province [103] 0 0
Stockholm
Country [104] 0 0
Switzerland
State/province [104] 0 0
Aarau
Country [105] 0 0
Switzerland
State/province [105] 0 0
Baden
Country [106] 0 0
Switzerland
State/province [106] 0 0
Bellinzona
Country [107] 0 0
Switzerland
State/province [107] 0 0
Bern
Country [108] 0 0
Switzerland
State/province [108] 0 0
Cham
Country [109] 0 0
Switzerland
State/province [109] 0 0
Chur
Country [110] 0 0
Switzerland
State/province [110] 0 0
Frauenfeld
Country [111] 0 0
Switzerland
State/province [111] 0 0
Freiburg
Country [112] 0 0
Switzerland
State/province [112] 0 0
Lausanne
Country [113] 0 0
Switzerland
State/province [113] 0 0
Locarno
Country [114] 0 0
Switzerland
State/province [114] 0 0
Lugano
Country [115] 0 0
Switzerland
State/province [115] 0 0
Mendrisio
Country [116] 0 0
Switzerland
State/province [116] 0 0
Olten
Country [117] 0 0
Switzerland
State/province [117] 0 0
Sion
Country [118] 0 0
Switzerland
State/province [118] 0 0
St. Gallen
Country [119] 0 0
Switzerland
State/province [119] 0 0
Thun
Country [120] 0 0
Switzerland
State/province [120] 0 0
Winterthur
Country [121] 0 0
Switzerland
State/province [121] 0 0
Zurich
Country [122] 0 0
United Kingdom
State/province [122] 0 0
England
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Breast International Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00553410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marco Colleoni, MD
Address 0 0
European Institute of Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00553410