The CONFIRM Study

CONFIRM studied FASLODEX 500 mg vs FASLODEX 250 mg

FASLODEX was tested in the CONFIRM study, which included postmenopausal women with HR-positive metastatic or locally advanced breast cancer who failed previous hormonal therapy. The goal of the study was to examine the effectiveness and safety of FASLODEX 500 mg vs FASLODEX 250 mg. Understanding this study may help you discuss FASLODEX with your doctor.

Patients in the CONFIRM study were postmenopausal women

Patients in the study

CONFIRM included 736 postmenopausal women with HR-positive metastatic or locally advanced breast cancer. Their cancer had spread during or within 12 months of receiving hormonal therapy.

where_cancer_spread-01

Where their cancer spread

Women in the CONFIRM study had cancer that spread to their bones, organs (including liver and lungs), and other soft tissues.

12_month-01

When their disease came back

In most cases, disease came back during hormonal treatment or within 12 months of completing previous hormonal therapy.

Effectiveness and safety results after a minimum 18-month follow-up

After patients were in the study for at least 18 months, results showed that FASLODEX 500 mg significantly extended the length of time during and after treatment that patients lived without their cancer getting worse. This measure, known as progression-free survival time, is one way to see how well a treatment works. Median progression-free survival time was 6.5 months in women who received FASLODEX 500 mg (n=362) vs 5.4 months in women who received FASLODEX 250 mg (n=374).

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

Overall survival, or the amount of time that passed until women in the study died of any cause, was not found to be statistically significant in CONFIRM. The median overall survival times were 25.1 months with FASLODEX 500 mg and 22.8 months with FASLODEX 250 mg after a minimum 18-month follow-up.

Results also indicated that women in the CONFIRM study experienced similar side effects regardless of which dose they received.

6.5 months’ progression free survival for FASLODEX 500 mg
5.4 months’ progression-free survival for FASLODEX 250 mg
6.5-months_1-4
5.4-months_1-4
26.4 months’ overall survival time for FASLODEX 500 mg
22.3 months’ overall survival time for FASLODEX 250 mg

HR=hormone receptor.

Effectiveness and safety results after a minimum 50-month follow-up

Overall survival was not found to be statistically significant in CONFIRM. The median overall survival times were 26.4 months for FASLODEX 500 mg and 22.3 months for FASLODEX 250 mg after a minimum 50-month follow-up.

There was no further analysis of progression-free survival, and the side effect profile of the 500 mg dose remained comparable to that of the 250 mg dose. Side effects observed in the study included injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; and increased liver enzymes.

26.4-months_1-4
22.3-months_1-4

HR=hormone receptor.

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).