Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4) (GIM4)
|ClinicalTrials.gov Identifier: NCT01064635|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2010
Last Update Posted : November 1, 2016
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 most effective in treating breast cancer in postmenopausal women who have received tamoxifen.
PURPOSE: This randomized phase III trial is comparing different regimens of letrozole to see how well they work in treating postmenopausal women with stage I, stage II, or stage III breast cancer previously treated with tamoxifen.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole||Phase 3|
- To compare the disease-free survival of previously treated, post-menopausal women with early-stage breast cancer treated with standard- (2-3 years of tamoxifen followed by 2-3 years of letrozole) versus long-treatment (2-3 years of tamoxifen followed by 5 years of letrozole) adjuvant letrozole.
- To compare the overall survival of these patients.
- To compare the safety of these patients.
OUTLINE: Patients are randomized to 1 or 2 treatment arms.
- Arm I (standard treatment): Patients previously treated with tamoxifen for 2 years receive letrozole for an additional 3 years; patients previously treated with tamoxifen for 3 years receive letrozole for an additional 2 years; and patients previously treated with tamoxifen for 2-3 years receive letrozole , so the total duration of the endocrine treatment (i.e., tamoxifen followed by letrozole) is 5 years.
- Arm II (long treatment): Patients receive letrozole for an additional 5 years regardless of the duration of the previous tamoxifen treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2056 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.|
|Study Start Date :||August 2005|
|Primary Completion Date :||August 2015|
Active Comparator: Letrozole for 3-2 years
Patients pre-treated with TAM for 2-3 years will receive letrozole 2,5 mg/die for 3-2 years. Total duration of early adjuvant endocrine therapy: 5 years
letrozole for 2-3 years after Tam
Experimental: Letrozole for 5 year
Patients pre-treated with TAM for 2-3 years will receive letrozole 2,5 mg/die for additional 5 years. Total duration of early adjuvant endocrine therapy: 7 years for patients pretreated with 2 years of TAM and 8 years for patients pre-treated with 3 years of TAM
Letrozole for 5 years after Tam
- Disease-free survival [ Time Frame: 6 years after the last patient enters the study ]
- Overall survival [ Time Frame: 6 years after the last patient enters the study ]
- Safety [ Time Frame: 6 years after the last patient enters the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064635
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Principal Investigator:||Lucia Del Mastro, MD||IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy|