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Advanced Breast Cancer (A5481082) Observational

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

Overview

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

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

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.
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Observational

Principal Investigator(s)

Steven Corso, MD

Sponsor(s)

Pfizer

Contact Us

Contact Us

To participate in this study, please contact Kathy Queen, RN at
864-560-1044
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