Test Your Knowledge With The BIG 1-98 Challenge From FEMARA® (letrozole)

BIG 1-98 is a large international clinical trial studying postmenopausal patients with hormone receptor positive (HR+) early breast cancer in the initial adjuvant setting.^1,2

To test your knowledge about BIG 1-98, answer the following 5 questions by clicking on your selected response.

You’re correct! BIG 1-98 has been studied in more than 8000 patients. This international phase 3, randomized, double-blind clinical trial is the largest initial adjuvant trial to compare an aromatase inhibitor with tamoxifen. Patients have been assessed at 26, 51, and 73-month median follow-up.^1-4

You’re correct! The adverse events reported most commonly in BIG 1-98 at any grade were hot flashes (33.5% versus 38.0% in tamoxifen), arthralgia (20.3% versus 12.3% in tamoxifen), and night sweats (13.9% versus 16.2% in tamoxifen).²

You’re correct! In the BIG 1-98 trial, there was a significant 19% reduction in the overall risk of recurrence versus tamoxifen at 26 months of follow-up (HR=0.81, 95% CI: 0.70-0.93, P=0.003).^2,5

You’re correct! BIG 1-98 showed a significant 27% reduction in the risk of the worst threat—distant metastases—versus tamoxifen at 26 months of follow-up (HR=0.73, 95% CI: 0.60-0.88, P=0.001).^2,5,6*

*Distant disease-free survival is a secondary end point of BIG 1-98; the primary end point of the study is disease-free survival. Approval is based on a median 26-month follow-up.⁵

You’re correct! At 73-month median follow-up in BIG 1-98, FEMARA^® is the only aromatase inhibitor versus tamoxifen to both significantly improve disease-free survival and time to distant recurrence.^4,7

BIG 1-98 has demonstrated that FEMARA^® can help protect your patients from the early risk of distant metastases.^2,5

When choosing an aromatase inhibitor in the initial adjuvant setting, look at the evidence—and choose FEMARA^® for your postmenopausal patients with HR+ early breast cancer.

FEMARA^® is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

References: 1. Fentiman IS. Optimising adjuvant endocrine treatment of breast cancer with aromatase inhibitors. Int J Clin Pract. 2006;60(6):689-693. 2. The Breast International Group (BIG) 1-98 Collaborative Group. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005;353(26):2747-2757. 3. 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. 2007;25(5):1-12. 4. Mouridsen H, for the BIG 1-98 Collaborative Group. Letrozole monotherapy vs. tamoxifen monotherapy or vs. letrozole in sequence with tamoxifen for postmenopausal women with endocrine-responsive early breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2008; San Antonio, Texas. 5. FEMARA^® (letrozole) [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; 2009. 6. Lamerato L, Havstad S, Gandhi S, Jones D, Chlebowski R. Breast cancer recurrence and related mortality in US pts with early breast cancer. In: Proceedings from the American Society of Clinical Oncology; May 13-17, 2005; Orlando, FL. Abstract 738. 7. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists’ Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008;9:45-53.

Take the BIG 1-98 data challenge