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Femara Clinical Data

Femara Clinical Data

Clinical Evidence Demonstrating the Efficacy and Safety of Femara for Postmenopausal Women in the Adjuvant, Extended Adjuvant and Advanced Cancer Settings

Novartis Oncology, the developer of Femara® (letrozole tablets), never stops searching for scientific discoveries that may benefit the lives of cancer patients, their families, and friends.

Original studies first showed Femara to be an effective treatment for postmenopausal women with advanced breast cancer. Since 1997, three large, international clinical trials have demonstrated the effectiveness of Femara at reducing the risk of breast cancer returning versus tamoxifen in postmenopausal women with hormone receptor-positive early stage breast cancer and reducing the risk of disease progression in women with advanced breast cancer, based on three studies with a median treatment duration ranging from about 10 months (P-025) to about 24 months (BIG 1-98 and MA-17). These three studies provided important results for the breast cancer community, and these important findings were widely published at the times of release.

Adjuvant Therapy: BIG 1-98 Trial

In postmenopausal women with hormone receptor-positive early stage breast cancer, in the adjuvant setting, Femara has been shown to help reduce the risk of breast cancer returning versus tamoxifen. This international study involving more than 8,000 postmenopausal women is based on a median treatment duration of 24 months. Further follow-up will be needed to determine long-term results, including safety and efficacy. Based on the results from this ongoing trial, which began in 1998, as well as other trials for aromatase inhibitors, the American Society of Clinical Oncology (ASCO) has revised the suggested guidelines to support the use of Femara versus tamoxifen in postmenopausal women with hormone receptor-positive early breast cancer.

Click here for more information on BIG 1-98.

Extended Adjuvant Therapy: MA-17

This international study involving more than 5000 women showed that, compared with placebo, Femara significantly reduced the risk of early stage breast cancer returning for postmenopausal women when taken within three months of completion of five years of tamoxifen therapy. This study was unblinded early, and subjects had the option to switch from placebo to Femara in the trial. The effectiveness of Femara is based on an analysis of disease-free survival in patients treated for a median treatment duration of 24 months. Further follow-up will be needed to determine long-term results, including side effects. As a result of this study, women now have a treatment option after five years of standard tamoxifen. Femara is the first treatment of its kind to be given after tamoxifen therapy.

Click here for more information on MA-17.

First-line Treatment of Advanced Breast Cancer: P-025 Trial

The P-025 trial demonstrated that Femara is superior to tamoxifen in the first-line endocrine treatment of advanced (metastatic) hormone receptor-positive or hormone receptor-unknown breast cancer in postmenopausal women. In the study, Femara was more effective at reducing the risk of disease progression compared with tamoxifen. An international study, P-025 involved more than 900 postmenopausal women with advanced breast cancer in 29 countries. It is the largest study of an aromatase inhibitor in the first-line treatment of advanced breast cancer.

Click here for more information on P-025.

Learn more about Femara patient programs Learn more about Femara patient programs

*The Femara Cares Program™ Prescription Discount Card allows you to pay only $10 for your Femara prescriptions, if you are eligible. Novartis Pharmaceuticals Corporation will pay the rest, up to a maximum of $800 in any 12-month period, toward your Femara prescriptions. This card is subject to change or termination at any time.

Not all patients will receive a total of $800 per year off their prescriptions. Total value of card determined by applicable patient co-pay or out-of-pocket cost.

The Femara Cares Program™ Prescription Discount Card is not valid for prescriptions for which payment may be made in whole or in part under federal or state healthcare programs, including but not limited to, Medicare or Medicaid, or for residents in MA. Limitations apply.

Indication
Femara® (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects.

In addition, Femara is approved for the treatment of postmenopausal women with estrogen receptor-positive or estrogen receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer). Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important Safety Information

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated in postmenopausal women. Talk to your doctor if you're allergic to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause harm to an unborn child. Some women reported fatigue and dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. The most common side effects seen with Femara include hot flashes, joint pain, night sweats, weight gain, nausea, tiredness, other heart-related events, and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack, and endometrial cancer.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Commonly reported side effects for Femara include hot flashes, fatigue, joint pain, headache, increase in sweating, swelling due to fluid retention, increase in cholesterol, dizziness, constipation, nausea, heart-related problems, muscle pain, osteoporosis, arthritis, and bone fracture.

In the metastatic cancer setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, tiredness, coughing, constipation, limb pain, chest pain, and headache.

Femara is a once-daily convenient prescription tablet.

For additional safety information, please see the prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.