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Palbociclib in Real World Practice

Last updated on October 16, 2019

FOR MORE INFORMATION
Study Location
St. Luke's University Health Network - Sacred Heart Hospital
Allentown, Pennsylvania, 18102 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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Descriptive Information
Brief TitlePalbociclib in Real World Practice
Official TitlePOLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY
Brief SummaryThis Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples With DNA
Description:
blood
Sampling MethodProbability Sample
Study PopulationHR+/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.
Condition
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
InterventionOther: non-interventional
Study Groups/Cohortsnon-interventional study
This prospective, observational study will be conducted according to each site's routine clinical practice.
Intervention: Other: non-interventional
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: September 8, 2017)
1500
Original Estimated EnrollmentSame as current
Estimated Study Completion DateJanuary 6, 2021
Estimated Primary Completion DateJanuary 6, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

    -

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesCanada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03280303
Other Study ID NumbersA5481082
POLARIS ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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