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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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2007-001370-88
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Secondary ID [2]
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IBCSG 35-07 / BIG 1-07
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Universal Trial Number (UTN)
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Trial acronym
SOLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free Survival (DFS)
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Assessment method [1]
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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.
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Timepoint [1]
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5-year estimates, reported at a median follow-up of 60 months
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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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).
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Timepoint [1]
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5-year estimates, reported at a median follow-up of 60 months
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Secondary outcome [2]
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Distant Recurrence-free Interval (DRFI)
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Assessment method [2]
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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
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Timepoint [2]
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5-year estimates, reported at a median follow-up of 60 months
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Secondary outcome [3]
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Breast Cancer-free Interval
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Assessment method [3]
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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.
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Timepoint [3]
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5-year estimates, reported at a median follow-up of 60 months
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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
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2019
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Sample size
Target
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Accrual to date
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Final
4884
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
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Recruitment hospital [1]
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Armidale Hospital - Armidale
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Bankstown - Lidcombe Hospital - Bankstown
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Southern Highlands Cancer Center - Bowral
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Concord Repatriation General Hospital - Concord
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Breast Center - Gateshead
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Port Mcquarie Base Hospital - Port Macquarie
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Prince of Wales Private Hospital - Randwick
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Tamworth Base Hospital - Tamworth
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Tweed Heads Hospital - Tweed Heads
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Calvary Mater Newcastle - Waratah
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North West Regional Hospital - Burnie
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Royal Hobart Hospital - Hobart
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Box Hill Hospital - Box Hill
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Peter MacCallum Cancer Centre - East Melbourne
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Austin Health - Heidelberg
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Maroondah Hospital - Melbourne
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Royal Perth Hospital - Perth
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2350 - Armidale
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2200 - Bankstown
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2576 - Bowral
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2139 - Concord
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2290 - Gateshead
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2444 - Port Macquarie
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2031 - Randwick
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2340 - Tamworth
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2485 - Tweed Heads
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2310 - Waratah
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7320 - Burnie
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7000 - Hobart
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3128 - Box Hill
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3002 - East Melbourne
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3084 - Heidelberg
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3135 - Melbourne
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Massachusetts
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Feldkirch
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Graz
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Baden
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Cham
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Switzerland
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Chur
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Switzerland
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Frauenfeld
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Switzerland
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Freiburg
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Switzerland
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Lausanne
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Switzerland
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Locarno
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Switzerland
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Lugano
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Switzerland
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Mendrisio
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Switzerland
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Olten
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Switzerland
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Sion
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Switzerland
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St. Gallen
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Switzerland
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Thun
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Switzerland
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Winterthur
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Switzerland
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Zurich
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United Kingdom
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England
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United Kingdom
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Scotland
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Funding & Sponsors
Primary sponsor type
Other
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Name
ETOP IBCSG Partners Foundation
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Other collaborator category [1]
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Other
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Breast International Group
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00553410
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Marco Colleoni, MD
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European Institute of Oncology
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/10/NCT00553410/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/10/NCT00553410/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00553410
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