The FALCON study

FALCON compared 2 treatments for postmenopausal patients’ first hormonal therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: FASLODEX 500 mg vs anastrozole 1 mg

Drugs like FASLODEX are tested in clinical studies to see how well they work and what types of side effects women who take them may experience before these drugs are approved for use. These studies are also known as clinical trials.

FALCON is one of the studies that examined FASLODEX. The goal of the study was to see how well FASLODEX worked when compared with anastrozole, another drug used to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer, and to examine what types of side effects women in the study experienced.

Based on the results of FALCON, FASLODEX may be prescribed as the first hormonal medicine for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in postmenopausal women. Your first hormonal medicine for advanced breast cancer is a complex choice influenced by many factors—talk to your doctor about what the FALCON study means for this decision.

Understanding this study may help you discuss FASLODEX with your doctor. FASLODEX may be an appropriate choice for your first hormonal therapy for advanced breast cancer.

462women

Patients in the study

The FALCON study included 462 postmenopausal women with locally advanced or metastatic breast cancer. All women tested hormone receptor-positive, and nearly all tested human epidermal growth factor receptor 2-negative.

In nearly all cases, their advanced cancer had not previously been treated with endocrine therapy.

priortreatment

Prior treatment

The FALCON study tested how well FASLODEX worked compared with anastrozole as the first endocrine therapy for locally advanced or metastatic breast cancer.

Some women may have received other types of treatment, such as chemotherapy or radiation, before the study began. Almost all women (99%) were not given endocrine therapy before the study began.

You may have been given endocrine therapy at some point in your advanced or metastatic breast cancer treatment—talk to your doctor if you are not sure what type(s) of treatment you have been previously given.

wherecancerspread

Where their cancer spread

Women in the FALCON study had cancer that spread to 1 or more parts of the body, such as organs (including lungs and liver), lymph nodes, and/or bones in addition to another location.

Additional information on the CONFIRM results

FASLODEX was proven superior to anastrozole in the FALCON study population

Results showed that FASLODEX 500 mg significantly extended the length of time during and after treatment that patients lived without their cancer getting worse compared with anastrozole 1 mg. This measure, known as progression-free survival time, is one way to see how well a treatment works. Progression-free survival can be displayed as the middle of a range of months, also known as the median.

Results of the FALCON study:

  • In 230 women who were given FASLODEX, the length of time they had without their cancer spreading was a median 16.6 months
  • In 232 women who were given anastrozole, the length of time they had without their cancer spreading was a median 13.8 months

The results of the FALCON study were shown to be statistically significant. Statistically significant results are important in studies like FALCON—this means that it is highly likely that the results are related to treatment instead of something else.

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IMPORTANT SAFETY INFORMATION

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat women with:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
  • HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
  • HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy

When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).

 
 
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IMPORTANT SAFETY INFORMATION

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat women with:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
  • HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
  • HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy

When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).