Advanced Breast Cancer (A5481082) Observational
Polaris: Palbociclib In Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-interventional Study
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.
To learn more, visit ClinicalTrials.Gov
Steven Corso, MD