UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	JBCRG(SOLE study)
Scientific Title	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
Scientific Title:Acronym	JBCRG(SOLE study)
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	Postmenopausal patients with breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare continuous letrozole for five years with intermittent letrozole over a five year period for postmenopausal women who are disease-free following 4-6 years of prior adjuvant endocrine therapy with SERM(s) and/or AI(s) for endocrine-responsive, node-positive, operable breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Disease-free survival (DFS): time from randomization to local (including invasive recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) malignancy, or death from any cause, whichever occurs first.
Key secondary outcomes	Overall survival (OS), distant disease-free survival (DDFS), breast cancer free interval (BCFI), sites of first failure, second (non-breast) malignancies, deaths without prior cancer events, and adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Continuous letrozole 2.5 mg daily for 5 years
Interventions/Control_2	B: Intermittent letrozole 2.5 mg daily for the first 9 months of years 1 through 4, followed by 12 months in year 5
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Completely resected, non-inflammatory breast cancer 2. ER and/or PgR positive 3. postmenopausal 4. Axillary and/or internal mammary lymph nodes positive 5. Any (neo-)adjuvant treatment 6. 4 to 6 years of SERM or AI treatment Last dose of SERM/AI within 1 year prior to randomization 7. No evidence of recurrence at any time 8. No bilateral breast cancer 9. No bone fracture due to osteoporosis during SERM/AI treatment 10. Pathology material from primary tumor available 11. No previous or concomitant malignancy 12. Signed informed consent
Key exclusion criteria	1. Patients must have clinically adequate hepatic function. 2. Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy. 3. Patients who have had any previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma. 4. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up. 5. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements.
Target sample size	4800

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Marco Colleoni
Organization	IBCSG/European Institute of Oncology
Division name	Division of Medical Onclogy
Zip code
Address	Via Ripamonti 435 20141 Milan,Italy
TEL	+39-2-5748-9439
Email	marco.colleoni@ieo.it

Public contact
1st name of contact person	1st name Middle name Last name Katsumasa Kuroi
Organization	Japan Breast Cancer Research Group (JBCRG)
Division name	Administrative office
Zip code
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL	+81-3-6264-8873
Homepage URL	http://www.jbcrg.jp/
Email	office@jbcrg.jp

Sponsor
Institute	International Breast Cancer Study Group
Institute
Department

Funding Source
Organization	International Breast Cancer Study Group
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Switzerland

Other related organizations
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Name of secondary funder(s)

IRB Contact (For public release)
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Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00553410
Org. issuing International ID_1	Clinical Trials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	熊本大学病院（熊本県）、都立駒込病院（東京都）、八尾市立病院（大阪府）、新潟県立がんセンター（新潟県）、大阪医療センター（大阪府）、広島大学病院（広島県）、四国がんセンター（愛媛県）、相原病院（大阪府）、北海道がんセンター（北海道）、筑波大学附属病院（茨城県）、九州がんセンター（福岡県）、相良病院（鹿児島県）、京都大学（京都府）、愛知県がんセンター（愛知県）、自治医科大学附属病院（栃木県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 10 Month 27 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005337

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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