First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

  • STATUS
    Recruiting
  • End date
    Apr 3, 2028
  • participants needed
    1900
  • sponsor
    Pfizer
Updated on 22 August 2021
endocrine therapy
hormone therapy
advanced breast cancer
HER2
fulvestrant
erbb2
anastrozole
palbociclib
exemestane
letrozole

Summary

This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.

Description

Patients diagnosed with HR+/HER2- locally advanced or metastatic breast cancer indicated by their treating physicians for first line endocrine-based palbociclib combination therapy and who meet eligibility criteria will be invited to participate in this study. The key objectives of this study are to describe clinical, scientific and patient reported outcomes for patients with HR+/HER2- locally advanced or metastatic breast cancer initiating treatment with first line endocrine-based palbociclib combination therapy in the real-world setting in Germany and Austria. Patient characteristics, real-world treatment patterns, treatment sequences and reasons for the physician's treatment decisions will be collected. Additional real-world research questions are to explore patient-focused parameters such as longitudinal follow-up data on patient-reported outcomes beyond disease progression and by treatment sequence or to analyze the time from the start of first line treatment to the first administered palliative chemotherapy. Clinical outcome by treatment sequences will be described. Routinely assessed biomarkers and diagnostic procedures applied for treatment sequence decisions will be collected.

Details
Condition tumor of the breast, breast tumors, breast tumor, Breast Cancer
Treatment Palbociclib + endocrine therapy
Clinical Study IdentifierNCT04767594
SponsorPfizer
Last Modified on22 August 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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