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Palbociclib in Real World Pra...

Palbociclib in Real World Practice

Last Updated: 2024-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-04

Study Completion Date

2022-12-22

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Breast Cancer Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-interventional study

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

non-interventional

Intervention Type OTHER

Interventions

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non-interventional

Intervention Type OTHER

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alabama Oncology

Alabaster, Alabama, United States

Site Status