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

Effect of talazoparib on the health and well-being of people with an inherited faulty BRCA gene and advanced breast cancer that has spread to their internal organs

Date of summary: September 2019

Study number: NCT01945775

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Study start date: October 2013

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Estimated study end date: September 2020

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The full title of this abstract is: Patient Reported Outcomes (PRO) in patients (pts) with HER2- advanced breast cancer (ABC) and a germline BRCA1/2 mutation (gBRCAm) receiving talazoparib (TALA) vs physician’s choice chemotherapy (PCT) in the EMBRACA trial: A focus on subgroups with/without visceral disease

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.

This summary reports the interim results from the study – results may not be the same when the study is complete.

 

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?

  • Advanced breast cancer is cancer that has spread within or beyond the breast to other parts of the body.
  • Some people with advanced breast cancer have the following:
    • A faulty BRCA gene within their DNA.
      • DNA is a molecule in a person’s cells that tells the cells how to work. A gene is a section of DNA that can tell the cell how to make a specific molecule, such as a protein.
        • Each gene has a unique name, which can be long. For this reason, genes are commonly known by a set of letters written in italics.
    • A type of breast cancer called human epidermal growth factor receptor 2-negative (known as HER2− breast cancer).
    • Cancer that has spread to their internal organs, such as the liver or lungs.
      • If a person has cancer that has spread to their internal organs, this could cause more pain and affect their well-being.
  • Talazoparib (TALA for short) is approved to treat people with advanced breast cancer and faulty BRCA genes inherited from a parent.
    • TALA stops a type of protein called PARP from repairing damaged DNA in some types of cancer cells (eg, cells that have a faulty BRCA gene). If cancer cells cannot repair their DNA, they will die.
  • The people in this study:
    • had HER2− advanced breast cancer and had inherited a faulty BRCA gene from a parent, and
    • filled in surveys about their health and well-being at the start, during, and at the end of the study.
  • The researchers wanted to check whether the health and well-being of people in this study were affected differently depending on whether:
    • they took TALA or were given their doctor’s choice of chemotherapy, and
    • their cancer had spread to their internal organs or not.
  • This summary describes the health and well-being of people in this study, based on the type of treatment they received and whether or not the cancer had spread to their internal organs, such as the liver or lungs.

Who took part in this study?

What were the results of the study?

  • Compared with people who received their doctor’s choice of chemotherapy, people in this study who took TALA had:
    • greater improvements in their health and well-being
    • less pain, and
    • a longer time before their pain got worse.
  • These results were similar whether people had cancer that had spread to their internal organs or not.

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

What were the main conclusions reported by the researchers?

  • In this study, people taking TALA had greater and longer-lasting improvements in both their health and well-being, and in their levels of pain, compared with people who received their doctor’s choice of chemotherapy.
    • These improvements with TALA were seen both in people whose cancer had spread to their internal organs and in people whose cancer had not spread to their internal organs.

Who sponsored this study?

This study was sponsored by Medivation, which was acquired by Pfizer Inc in September 2016.

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

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

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