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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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