Status:

COMPLETED

Palbociclib in Real World Practice

Lead Sponsor:

Pfizer

Conditions:

Advanced Breast Cancer

Metastatic Breast Cancer

Eligibility:

All Genders

18+ years

Brief Summary

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Age ≥18 years or older.
  • Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
  • Documented HR+ (ER+ and/or PR+) tumor based on local standards.
  • Documented HER2- tumor based on local standards.
  • Physician has determined that treatment with palbociclib is indicated.
  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.
  • Exclusion Criteria:
  • Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.
  • Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
  • Patients on active treatment for malignancies other than ABC at the time of enrollment.
  • Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
  • \-

Exclusion

    Key Trial Info

    Start Date :

    January 4 2017

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 22 2022

    Estimated Enrollment :

    1285 Patients enrolled

    Trial Details

    Trial ID

    NCT03280303

    Start Date

    January 4 2017

    End Date

    December 22 2022

    Last Update

    September 20 2024

    Active Locations (305)

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    Page 1 of 77 (305 locations)

    1

    Alabama Oncology

    Alabaster, Alabama, United States, 35007

    2

    Alabama Oncology

    Bessemer, Alabama, United States, 35022

    3

    Alabama Oncology

    Birmingham, Alabama, United States, 35205

    4

    Alabama Oncology

    Birmingham, Alabama, United States, 35209