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A5481082: Advanced Breast Cancer, Observational

Polaris: Palbociclib In Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-interventional Study

Objective

Overview

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

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • 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.

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • 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.

Phase: N/A

Learn More

ClinicalTrials.Gov

IRB Protocol Number
A5481082
Principal Investigator(s)
Dr. Steven Corso, M.D.

Clinical Trial Categories

  • Breast Cancer
Sponsor(s)
Pfizer
How to Participate

Kathy Queen, RN
864-560-1044
kqueen@gibbscc.org

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