Conclusions: The BIG study update with median follow up of 76 months confirms a significant reduction in the risk of breast cancer recurrence and a trend towards improved overall survival with letrozole as compared to tamoxifen, and no unexpected safety concerns with letrozole. Adjuvant endocrine treatment should preferentially be initiated with letrozole.
For patients unable to continue letrozole, switching to tamoxifen appears to be an acceptable alternative. Abstract Background and methods: There is accumulating data on the clinical benefit of aromatase inhibitors in the adjuvant treatment of early-stage breast cancer in postmenopausal women.
In postmenopausal women with endocrine-responsive breast cancer, adjuvant treatment with letrozole, as compared with tamoxifen, reduced the risk of recurrent disease, especially at distant sites. This website uses cookies.
By using this website you agree to use these cookies in accordance with the current browser settings. Home Projects BIG Methods The Breast International Group BIG study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor—positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole.
Results A total of women with data that could be assessed were enrolled, in the letrozole group and in the tamoxifen group. Regardless of prior hormonal replacement therapy HRT or hysterectomy:.
Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : December 12, Study Description.
Detailed Description:. Compare these treatment regimens given sequentially vs continuously in this patient population. Compare these treatment regimens in terms of overall survival, disease-free and systemic-free survival, safety, and tolerability in this patient population.
Arm I: Patients receive adjuvant oral tamoxifen daily for 5 years. Arm II: Patients receive adjuvant oral letrozole daily for 5 years. Arm III: Patients receive adjuvant oral tamoxifen daily for 2 years followed by adjuvant oral letrozole daily for 3 years. Arm IV: Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant oral tamoxifen daily for 3 years.
Patients are followed annually. MedlinePlus related topics: Breast Cancer. Drug Information available for: Tamoxifen Tamoxifen citrate Letrozole. FDA Resources. Arms and Interventions.
Tamoxifen for 2 years after randomization, then letrozole for the next 3 years. Letrozole for 2 years after randomization, then tamoxifen for the next 3 years.
Outcome Measures. Primary Outcome Measures : Disease free survival. Secondary Outcome Measures : Overall survival [ Time Frame: Up to end of year ] Time from randomization to death from any cause, assessed up to end of year , for a maximum of 17 years. Time from randomization to appearance of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation, or the contralateral breast, assessed up to end of year , for a maximum of 17 years.
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Please refer to this study by its ClinicalTrials. Gallen St. Gallen, Switzerland, CH More Information. Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG study. J Clin Oncol. Epub Feb Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG trial. Ann Oncol. Epub Oct Breast Cancer Res Treat. Epub Nov 3.
Lancet Oncol. Interpreting Breast International Group BIG a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer.
Breast Cancer Res. Which patients benefit most from adjuvant aromatase inhibitors?
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