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 : Active, not recruiting
First Posted : November 5, 2007
Last Update Posted : March 6, 2018
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|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
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: estimated 10 years after first patient in ]
- Overall survival [ Time Frame: estimated 10 years after first patient in ]
- Distant DFS [ Time Frame: estimated 10 years after first patient in ]
- Breast cancer-free interval [ Time Frame: estimated 10 years after first patient in ]
- Sites of first DFS failure [ Time Frame: estimated 10 years after first patient in ]
- Second (nonbreast) malignancies [ Time Frame: estimated 10 years after first patient in ]
- Deaths without prior cancer events [ Time Frame: estimated 10 years after first patient in ]
- Adverse events [ Time Frame: estimated 10 years after first patient in ]
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
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|Study Chair:||Marco Colleoni, MD||European Institute of Oncology|