FASLODEX study results

CONFIRM studied FASLODEX 500 mg vs FASLODEX 250 mg

FASLODEX was tested in the CONFIRM study, which included postmenopausal women with hormone receptor-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.

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Patients in the study

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

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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.

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When their disease came back

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

Additional information on the CONFIRM results

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).

These results, which were shown to be statistically significant, indicate that women who received FASLODEX 500 mg were 20% less likely to have their cancer progress than were women who received FASLODEX 250 mg in the same amount of time. This can be referred to as a 20% decrease in relative risk of disease progression.

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.

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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.

IMPORTANT SAFETY INFORMATION

  • You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include: itching; swelling of your face, lips, tongue, or throat; trouble breathing
  • Before receiving FASLODEX, tell your healthcare 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 healthcare provider if you take a blood thinner medicine (anticoagulants)
  • Have liver problems
  • Are pregnant or plan to become pregnant, as FASLODEX can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment with FASLODEX and for one year after the last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breast-feeding or plan to breast-feed. It is not known if FASLODEX passes into breast milk. Do not breast-feed during treatment with FASLODEX and for one year after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time
  • FASLODEX is administered as a shot into the muscle of your buttock.

    FASLODEX may cause injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness; tingling; weakness.

    The most 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; and increased liver enzymes.

Tell your healthcare 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 healthcare provider or pharmacist.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat:

  • hormone receptor (HR)-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine, OR
  • HR-positive, human epidermal growth factor receptor 2 (HER2)‐negative breast cancer whose disease has spread to other parts of the body (metastatic) in combination with palbociclib in women with disease progression after hormonal therapy
  • When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

Please see FASLODEX Prescribing Information with Patient Information.

 
 
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IMPORTANT SAFETY INFORMATION

  • You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include: itching; swelling of your face, lips, tongue, or throat; trouble breathing
  • Before receiving FASLODEX, tell your healthcare 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 healthcare provider if you take a blood thinner medicine (anticoagulants)
  • Have liver problems
  • Are pregnant or plan to become pregnant, as FASLODEX can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment with FASLODEX and for one year after the last dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breast-feeding or plan to breast-feed. It is not known if FASLODEX passes into breast milk. Do not breast-feed during treatment with FASLODEX and for one year after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time
  • FASLODEX is administered as a shot into the muscle of your buttock.

    FASLODEX may cause injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness; tingling; weakness.

    The most 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; and increased liver enzymes.

Tell your healthcare 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 healthcare provider or pharmacist.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat:

  • hormone receptor (HR)-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine, OR
  • HR-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer whose disease has spread to other parts of the body (metastatic) in combination with palbociclib in women with disease progression after hormonal therapy
  • When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.