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SOLE
GLOBAL
SOLE study
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
- Status
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No Longer Recruiting
- Objectives
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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.
- Subjects
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- Endpoints
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Primary end point: 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. Secondary end points: 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.
- Trial Period
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5 years registration, 1 year follow up
- Lead Principal Investigator
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Norikazu Masuda(Dept of Surgery,Osaka National Hospital), Kenjiro Aogi(Department of Breast and Endocrine Surgery,Shikoku Cancer Center)
- Target Sample Size
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4800 (1600 x 3 years) Internationaly
- Regimen
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- Source of Funding
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IBCSG(Internatinal Breast Cancer Study Group), BIG(Breast Internatinal Group), JBCRG（Japan Breast Cancer Research Group)
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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UMIN000004458
- jRCT
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- Memo
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- COI Disclosure
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