Home
About Femara
-  Reduction of Risk of HR+    Early Breast Cancer    Returning
-  How Femara Works
-  Femara Clinical Data
Femara vs. Tamoxifen
Reduced Risk After Tamoxifen Therapy
Reduced Risk of
Disease Progression
The BIG 1-98 Study
Therapy After Surgery
Healthy Living Tips
Patient Programs
About Breast Cancer
Femara vs. Tamoxifen

Femara vs. Tamoxifen

Breast International Group (BIG) 1-98: The Femara
Adjuvant Therapy Trial

Background

For nearly 30 years, tamoxifen had been the gold standard in the treatment of breast cancer for postmenopausal women. In 1998, the International Breast Cancer Study Group (IBCSG) began a worldwide clinical trial known as BIG 1-98. The study involved more than 8,000 postmenopausal women. Among other things, it was designed to compare the effects of Femara® (letrozole tablets) vs tamoxifen in postmenopausal women with hormone receptor-positive early stage breast cancer. Preliminary results from the study showed that at 26 months of follow up, Femara was more effective than tamoxifen at reducing the risk of breast cancer returning in postmenopausal women with hormone receptor-positive early stage breast cancer. Half of the women received tamoxifen while the other half received Femara.

Results Summary

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. Based on the results of this large, international study at a median treatment duration of 24 months, Femara was approved for the adjuvant therapy of postmenopausal women with hormone receptor-positive early stage breast cancer. Further follow-up will be needed to determine long-term results, including safety and efficacy. Now women have an effective option to consider when discussing adjuvant treatment with their oncologists.

In postmenopausal women with hormone receptor-positive early breast cancer in the adjuvant setting:
Femara vs. Tamoxifen in the Adjuvant Setting

Click here for important safety information for Femara.

Remember to take your medicine as prescribed by your doctor.



Learn More About:

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.