FASLODEX with palbociclib study results

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

FASLODEX with palbociclib was tested in the PALOMA-3 study, which included women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with hormonal therapy. The goal of the study was to examine the effectiveness and safety of FASLODEX 500 mg with palbociclib 125 mg vs FASLODEX 500 mg and placebo. Understanding this study may help you discuss FASLODEX with palbociclib with your doctor.

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

paloma-3_-01

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.

where cancer spread 2-01

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.

prior_treatment-01

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

Analysis indicated that women who received FASLODEX 500 mg with palbociclib 125 mg (n=347) experienced about double the amount of time before cancer progressed, also known as progression-free survival time, compared with those who received FASLODEX and placebo (n=174). Median progression-free survival time was 9.5 months vs 4.6 months, respectively.

These results, which were shown to be statistically significant, indicate that women who received FASLODEX 500 mg and palbociclib were 54% less likely to have their cancer progress than were women who received FASLODEX and placebo in the same amount of time. This can be referred to as a 54% decrease in relative risk of disease progression.

paloma_3_Times-02
paloma_3_Times-01
paloma_3-Times-02-mobile
paloma_3_Times-01-mobile

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.

 
 
Read More

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.