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This is an international site for FEMARA® (letrozole) and is intended for Health Care Professionals outside the U.S. The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.

Femara and Breast Cancer Information for International Healthcare Professionals Femara and Breast Cancer Information for US residents Femara and Breast Cancer Information for Patients Outside the US

In the initial adjuvant setting,

Although Annette may be considered "low risk," the risk of distant metastases is still a very real threat

Even patients like Annette with tumours ≤2 cm and no nodal involvement have a 1 in 5 risk of distant metastases1*



Nearly 4 out of 5 patients are at risk of dying within 5 years when distant metastases are the first recurrence4

Overall survival according to first event4
Chart: Overall survival according to first event
Adapted from Le et al.4

The data reflected in this chart are estimates only and do not take into account individual results.

FEMARA® (letrozole) is the only aromatase inhibitor versus tamoxifen that significantly reduces the early risk of distant metastases5,6†‡

At 26-month follow-up, FEMARA® delivered:



At 73-month median follow-up, FEMARA® remains the only aromatase inhibitor versus tamoxifen to7,8:



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At a median follow-up of 73 months and a median treatment duration of 60 months, the risk of a disease-free survival event was significantly reduced with FEMARA® compared with tamoxifen (intent-to-treat [ITT] analysis: HR 0.87; 95% CI: 0.76-0.99; P=0.03; censored analysis: HR 0.84; 95% CI: 0.73-0.95), confirming the 2005 PCA results.9

Similarly, the updated analysis confirmed the superiority of FEMARA® in reducing the risk of distant metastases (HR 0.85; 95% CI: 0.72-1.00). Additionally, while not statistically significant, overall survival trended toward significance in the ITT analysis.9

Explanation of ITT versus censored analyses

ITT analyses were conducted ignoring the selective crossover. Censored analyses were conducted censoring follow-up/event times at the date of selective crossover in 632 women (26%) who crossed to FEMARA® or another aromatase inhibitor after the tamoxifen arms were unblinded in 2005, based on superior efficacy of FEMARA® over tamoxifen and following the recommendations of the Data Monitoring Committee.9

Of these 632 women, 448 (70%) crossed to FEMARA® to complete initial adjuvant therapy. All of these women were in Option 1 and most crossed in Years 3 to 4, at a median 43 months from randomization. Median duration of FEMARA® after crossing was 17 months. The remaining 184 women crossed to FEMARA® (172 women) or another aromatase inhibitor (12 women) to start extended adjuvant treatment, having received tamoxifen for 4.5 to 5 years.9

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Because even your "low-risk" patients with early breast cancer are at real risk for distant metastases1...

Start and stay with FEMARA® (letrozole) to help prevent distant metastases5,7

Return to Case Studies.

To read more about the unique efficacy profile of FEMARA®, click here.

*Average risk over 15 years based on prognostic factors of nodal status and tumor size.1
†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
‡Standard adjuvant treatment duration is 5 years or until relapse.5

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

Click here for Important Safety Information for FEMARA®.

References: 1. Heimann R, Hellman S. Clinical progression of breast cancer malignant behavior: what to expect and when to expect it. J Clin Oncol. 2000;18(3):591-599. 2. Mansell J, Monypenny IJ, Skene AI, et al. Distant metastasis—the most common type of early recurrence with adjuvant tamoxifen therapy. Poster presented at: 30th Annual San Antonio Breast Cancer Symposium; December 13-16, 2007; San Antonio, Texas. 3. 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. 4. Le MG, Arriagada R, Spielmann M, Guinebretiere J-M, Rochard F. Prognostic factors for death after an isolated local recurrence in patients with early-stage breast carcinoma. Cancer. 2002;94(11):2813-2820. 5. FEMARA® (letrozole) [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; 2009. 6. Gradishar W. Landmark trials in endocrine adjuvant therapy for breast carcinoma. Cancer. 2006;106(5):975-981. 7. 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: 31st Annual San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2008; San Antonio, Texas. 8. 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 9. Data on file. Novartis Oncology, East Hanover, NJ.