The PALOMA-3 study: FASLODEX in combination with palbociclib

PALOMA-3 studied FASLODEX 500 mg with palbociclib 125 mg vs FASLODEX and placebo*

Drugs like FASLODEX are tested in clinical studies to see how well they work before they are approved for use. These studies are also known as clinical trials.

PALOMA-3 is one of the studies that examined FASLODEX. The goal of the study was to see how well FASLODEX with palbociclib worked vs FASLODEX and placebo in advanced or metastatic breast cancer, and to examine what kind of side effects women in the study experienced.

Based on the results of PALOMA-3, FASLODEX with palbociclib can be used to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in postmenopausal women whose disease progressed after endocrine therapy, which is a type of medicine used to treat breast cancer. Your breast cancer therapy is a complex choice influenced by many factors—talk to your doctor about what the PALOMA-3 study may mean for this decision.

Understanding this study may help you discuss FASLODEX with your doctor. FASLODEX with palbociclib may be an appropriate choice to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer with disease progression after endocrine therapy.

*Placebo refers to pills that do not contain an active medicine.

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Patients in the study

PALOMA-3 included 521 women who had either been through menopause or been given medication that began menopause. These women had hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Their cancer had spread on or after previous endocrine therapy.

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Where their cancer spread

Women in the PALOMA-3 study had cancer that spread to between 1 and 3 or more locations. These locations included organs (including lungs and liver) and bones.

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Prior treatment for metastatic disease

All women (100%) had been given prior treatment. Most (75%) had been given previous chemotherapy.

Additional information on the PALOMA-3 results

Analysis of the PALOMA-3 study

Results showed that FASLODEX 500 mg with palbociclib 125 mg (n=347) significantly extended the length of time during and after treatment that patients lived without their cancer getting worse compared with FASLODEX and placebo (n=174). 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.

Median progression-free survival time was 9.5 months vs 4.6 months, respectively, showing that women who received FASLODEX with palbociclib experienced more than double the progression-free survival time than did women who received FASLODEX and placebo.

These results were shown to be statistically significant. Statistically significant results are important in studies like PALOMA-3—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).