Bookmark this pageiconPrint this pageE-mail this page

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,

Astrid's first priority is keeping distant metastases out of the picture

Even patients with small tumors without nodal involvement have a 1 in 5 risk of distant metastases1*



FEMARA® (letrozole) is the only aromatase inhibitor versus tamoxifen that significantly reduces the risk of distant metastases during 26-month follow-up4,5†‡

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



Standard adjuvant treatment duration is 5 years or until relapse4...

At 73-month median follow-up, FEMARA® remains the only aromatase inhibitor versus tamoxifen to both6,7:



Click here for more information.

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.8

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.8

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.8

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.8

Click here for more information.

BIG 1-98 monotherapy update at 73-month median follow-up6
Chart: BIG 1-98 monotherapy update at median 76-month follow-up
§FEMARA®:tamoxifen-breast cancer events, 321:363; second (nonbreast) malignancy, 101:115; deaths without
  prior cancer event, 87:87.3

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

Because your early breast cancer patients' priority is to keep distant metastases out of the picture...

Start and stay with FEMARA® (letrozole) to help prevent distant metastases4,6

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.4
‡Standard adjuvant treatment duration is 5 years or until relapse.4

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. Schairer C, Mink PJ, Carroll L, Devesa SS. Probabilities of death from breast cancer and other causes among female breast cancer patients. J Natl Cancer Inst. 2004;96(17):1311-1321. 4. FEMARA® (letrozole) [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; 2009. 5. Gradishar W. Landmark trials in endocrine adjuvant therapy for breast carcinoma. Cancer. 2006;106(5):975-981. 6. 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. 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. 8. Data on file. Novartis Oncology, East Hanover, NJ.