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Reduced risk after tamoxifen therapy

Reduced Risk After Tamoxifen Therapy

MA-17 Extended Adjuvant Therapy Trial

Background

After surgery, breast cancer returns in one out of three women with early stage breast cancer.Based on the risks, the National Cancer Institute of Canada embarked on a 5-year international study known as MA-17. The trial involved more than 5,000 postmenopausal women with hormone receptor-positive early stage breast cancer.

Study Specifications

Postmenopausal women had to have received tamoxifen for approximately five years and be within three months of completion of tamoxifen therapy to be eligible for the study. Half of the women received Femara® (letrozole tablets) and the other half received placebo (sugar pills).

Results Summary

The study demonstrated that Femara significantly reduced the risk of early stage breast cancer returning when taken within three months of completion of five years of tamoxifen. 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. Results were published promptly in the November 2003 New England Journal of Medicine.

In postmenopausal women with early stage breast cancer who are within three months of completion of five years of tamoxifen therapy:
Femara vs. Placebo in the Extended Adjuvant Setting

Click here for important safety information for Femara.

Remember to take your medicine as prescribed by your doctor.


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*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.