Palbociclib in Real World Practice

Purpose

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

Conditions

  • Advanced Breast Cancer
  • Metastatic Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
non-interventional study This prospective, observational study will be conducted according to each site's routine clinical practice.
  • Other: non-interventional

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

NCT ID
NCT03280303
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com