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)
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|ClinicalTrials.gov Identifier: NCT00553410|
Recruitment Status : Completed
First Posted : November 4, 2007
Results First Posted : January 29, 2019
Last Update Posted : March 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole||Phase 3|
- Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4884 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2007|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||May 15, 2019|
Active Comparator: Continuous letrozole
Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)
Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
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
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
- Disease-free Survival (DFS) [ Time Frame: 5-year estimates, reported at a median follow-up of 60 months ]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.
- Overall Survival [ Time Frame: 5-year estimates, reported at a median follow-up of 60 months ]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) [ Time Frame: 5-year estimates, reported at a median follow-up of 60 months ]
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 [ Time Frame: 5-year estimates, reported at a median follow-up of 60 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553410
|Study Chair:||Marco Colleoni, MD||European Institute of Oncology|