Phase III Randomized Study of Adjuvant Letrozole Versus Tamoxifen in Postmenopausal Women With Operable, Hormone Receptor-Positive Breast Cancer
Alternate Title Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment A total of 5,180 patients (1,295 per treatment arm) will be accrued for this study within 6 years. Outline This is a randomized, double-blind, multicenter study. Patients are stratified according to adjuvant chemotherapy (prior therapy vs no prior or concurrent therapy vs concurrent therapy), prior surgery (modified radical mastectomy vs a lesser surgical procedure), and participating center. Patients are randomized to one of four treatment arms.
Patients may receive concurrent radiotherapy. Some patients receive concurrent adjuvant chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months. Patients are followed annually. Published ResultsCrivellari D, Sun Z, Coates AS, et al.: Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial. J Clin Oncol 26 (12): 1972-9, 2008.[PUBMED Abstract] Doughty JC: A review of the BIG results: the Breast International Group 1-98 trial analyses. Breast 17 (Suppl 1): S9-S14, 2008.[PUBMED Abstract] Rasmussen BB, Regan MM, Lykkesfeldt AE, et al.: Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial. Lancet Oncol 9 (1): 23-8, 2008.[PUBMED Abstract] Coates AS, Keshaviah A, Thürlimann B, et al.: Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol 25 (5): 486-92, 2007.[PUBMED Abstract] Coates AS, Mouridsen H, Sun Z, et al.: Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: updated safety analysis of trial BIG 1-98. [Abstract] J Clin Oncol 25 (Suppl 18): A-521, 2007. Crivellari D, Sun Z, Coates AS, et al.: Aromatase inhibitors (AI) for elderly patients: efficacy, compliance and safety according to patient age in the BIG 1-98 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9033, 501s, 2007. Koeberle D, Thuerlimann B: Letrozole as upfront endocrine therapy for postmenopausal women with hormone-sensitive breast cancer: BIG 1-98. Breast Cancer Res Treat 105 (Suppl 1): 55-66, 2007.[PUBMED Abstract] Mauriac L, Keshaviah A, Debled M, et al.: Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Ann Oncol 18 (5): 859-67, 2007.[PUBMED Abstract] Monnier AM: The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer. Expert Rev Anticancer Ther 7 (5): 627-34, 2007.[PUBMED Abstract] Mouridsen H, Keshaviah A, Coates AS, et al.: Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 trial. J Clin Oncol 25 (36): 5715-22, 2007.[PUBMED Abstract] Rasmussen BB, Regan MM, Lykkesfeldt AE, et al.: Central assessment of ER, PgR and HER2 in BIG 1-98 evaluating letrozole (L) compared to tamoxifen (T) as initial adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. [Abstract] J Clin Oncol 25 (18 Suppl 20): A-538, 2007. Viale G, Regan MM, Maiorano E, et al.: Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J Clin Oncol 25 (25): 3846-52, 2007.[PUBMED Abstract] Forbes JF: The use of early adjuvant aromatase inhibitor therapy: contributions from the BIG 1-98 letrozole trial. Semin Oncol 33 (2 Suppl 7): S2-7, 2006.[PUBMED Abstract] Thürlimann B, Keshaviah A, Coates AS, et al.: A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 353 (26): 2747-57, 2005.[PUBMED Abstract] Related PublicationsDelea TE, El-Ouagari K, Karnon J, et al.: Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-receptor positive early breast cancer from a Canadian perspective. Breast Cancer Res Treat 108 (3): 375-87, 2008.[PUBMED Abstract] Delea TE, Karnon J, Sofrygin O, et al.: Cost-effectiveness of letrozole versus tamoxifen as initial adjuvant therapy in hormone receptor-positive postmenopausal women with early-stage breast cancer. Clin Breast Cancer 7 (8): 608-18, 2007.[PUBMED Abstract] Buzdar A, Chlebowski R, Cuzick J, et al.: Defining the role of aromatase inhibitors in the adjuvant endocrine treatment of early breast cancer. Curr Med Res Opin 22 (8): 1575-85, 2006.[PUBMED Abstract] Scott LJ, Keam SJ: Letrozole : in postmenopausal hormone-responsive early-stage breast cancer. Drugs 66 (3): 353-62, 2006.[PUBMED Abstract] Wardley AM: Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17. Clin Breast Cancer 6 (Suppl 2): S45-50, 2006.[PUBMED Abstract] Trial Lead Organizations International Breast Cancer Study Group
Federation Nationale des Centres de Lutte Contre le Cancer
Danish Breast Cancer Cooperative Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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