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Palbociclib in Real World Practice

Last updated on April 19, 2018

FOR MORE INFORMATION
Study Location
Alabama Oncology
Alabaster, Alabama, 35007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Breast Cancer, Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT03280303
Pfizer
Recruiting
Palbociclib in Real World Practice

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Palbociclib in Real World Practice
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
blood
Probability Sample
HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
Other: non-interventional
non-interventional study
This prospective, observational study will be conducted according to each site's routine clinical practice.
Intervention: Other: non-interventional
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
January 1, 2022
December 16, 2021   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03280303
A5481082
POLARIS ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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