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Reduced Risk of Disease Progression

Reduced Risk of Disease Progression

P-025: First-line Treatment of Advanced (Metastatic) Breast Cancer

Metastasis means the spread of cancer. A patient with metastatic hormone receptor-positive or hormone receptor-unknown breast cancer has cancer cells that have spread from the breast to another part or parts of the body. It's not possible to have metastatic breast cancer without having a primary tumor. For example, if breast cancer spreads to the lungs, the metastatic tumor in the lungs is composed of cancerous breast cells, not lung cells. Treatment for metastatic hormone receptor-positive or hormone receptor-unknown breast cancer depends on the type, location, and size of the cancer and may include chemotherapy, radiation, hormone therapy, and/or Surgery.

Background

The P-025 trial was a randomized, double-blind, multinational trial conducted in 916 postmenopausal women with locally advanced or metastatic hormone receptor-positive or hormone receptor-unknown breast cancer.

Results Summary

Results of the largest single study to date conducted with an aromatase inhibitor in the first-line endocrine treatment of advanced (metastatic) hormone receptor-positive or hormone unknown breast cancer showed that treatment with Femara® (letrozole tablets) was more effective than tamoxifen, an established first-line endocrine therapy, in the following key measures.

Femara is a hormonal drug that has been shown to be superior to tamoxifen in the locally advanced or metastatic hormone receptor-positive or hormone receptor-unknown breast cancer setting.

  • 57% prolonged median time to progression versus tamoxifen
    (9.4 months versus 6.0 months, P<0.0001) (primary end point)
  • 30% reduction in risk of progression (P=0.0001)
    [Median time to progression was 9.4 months for 453 patients treated with Femara versus 6.0 months for 454 patients treated with tamoxifen.]
  • 71% increase in the odds of responding to treatment (P=0.0006)
    [One hundred and thirty six out of 453 (30%) patients treated with Femara responded to treatment versus ninety one out of 454 (20%) patients treated with tamoxifen - Odds Ratio (1.71; 95% CI. 1.26 to 2.31, P=.0006)]
  • Femara was generally well tolerated as a convenient 2.5-mg, once-daily dose

Click here for important safety information for Femara.

Remember to take your medicine as prescribed by your doctor.

Femara is approved for the treatment of postmenopausal women with hormone receptor-positive or hormone 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.


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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.