Palbociclib in Real World Practice

Pfizer

Status: Completed

Conditions: Metastatic Breast Cancer; Advanced Breast Cancer

Treatments: Other: non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03280303

A5481082

POLARIS (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥18 years or older.
2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
3. Documented HR+ (ER+ and/or PR+) tumor based on local standards.
4. Documented HER2- tumor based on local standards.
5. Physician has determined that treatment with palbociclib is indicated.
6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
7. 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:

1. Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment.

2. 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).

3. Patients on active treatment for malignancies other than ABC at the time of enrollment.

4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

Trial design

1,285 participants in 1 patient group

non-interventional study

Description:

This prospective, observational study will be conducted according to each site's routine clinical practice.

Treatment:

Other: non-interventional