Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

The effect of palbociclib on frailty and daily functioning in older women with advanced breast cancer

Date of summary: September 2019

Study number: NCT03280303

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Study start date: January 2017

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Estimated study end date: January 2021

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The full title of this abstract is: Measures of functional status in adults aged ≥70 years with advanced breast cancer (ABC) receiving palbociclib (PAL) combination therapy in POLARIS

This study drug is approved to treat the condition under study that is discussed in this summary.

 

Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.

 

More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • People can have different types of breast cancer. Knowing which type of breast cancer a person has can help the doctor and patient choose the most appropriate treatment option.
  • Advanced breast cancer is cancer that has spread within or beyond the breast. If the cancer has spread beyond the breast, it is also called metastatic breast cancer.
    • Some breast cancers are sensitive to hormones such as estrogen, which cause the cancers to grow. People with this type of breast cancer have hormone receptor positive (HR+) cancer; people without it have hormone receptor negative (HR−) cancer.
    • Changes to genes within some breast cancers cause cells to make too much of a protein that stimulates their growth. This protein is called human epidermal growth factor receptor 2 (HER2 for short). People with this type of breast cancer have HER2+ cancer; people without it have HER2− cancer.
  • Palbociclib + hormone therapy is an approved treatment in Europe for people with HR+/HER2− advanced or metastatic breast cancer.
    • Palbociclib + hormone therapy may stop cancer cells from multiplying, which can help slow down or stop the spread of the cancer.
  • This ongoing study is called POLARIS.
    • Researchers are looking at the treatment effects of palbociclib in women with HR+/HER2− advanced breast cancer in the United States (US) and Canada.
    • Researchers are also looking at women’s frailty and daily functioning.
      • Frailty is a condition of declining health and/or strength, which may affect older people or those with advanced disease.
      • Daily functioning is a person’s ability to perform the normal activities of everyday life.
  • POLARIS is a ‘real-world’ study, not a clinical trial.
    • In clinical trials, the treatments that people receive are often tightly controlled so that researchers can test the effect of a new drug.
    • In real-world studies, people receive approved drugs in a normal clinical practice setting. This helps researchers understand how drugs are used in real life.
  • This summary describes:
    1. How palbociclib may affect frailty and daily functioning in older women.
    2. How women’s well-being and activity level may affect their frailty and daily functioning

Who took part in this study?

What were the results of the study?

1. How did palbociclib affect frailty and daily functioning?

  • After 6 months of palbociclib treatment, older women with advanced breast cancer were:
    • likely to maintain the same level of frailty as before treatment, and
    • likely to maintain their ability to perform daily activities as before treatment.

2. How did well-being and activity level affect frailty and daily functioning?

  • Women who were well and fully active before starting treatment were:
    • more likely to have low levels of frailty both before and 6 months after starting treatment, and
    • more likely to have normal ability to perform daily activities before starting treatment.
  • Women who were fully active 6 months after starting treatment were:
    • more likely to have low levels of frailty both before and 6 months after starting treatment, and
    • more likely to have normal ability to perform daily activities before starting treatment.

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • This study provides ‘real-world’ insights into palbociclib as a treatment for older women with HR+/HER2− advanced breast cancer.
  • After 6 months of palbociclib treatment, similar numbers of women had a high level of frailty and decreased daily functioning as before treatment.
  • Women who are 70 years of age or older and are well and active before and after 6 months of treatment may be more likely to have:
    • low levels of frailty, and
    • normal ability to perform daily activities.

 

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY,
NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the women who took part in this study.

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