Palbociclib in Real World Practice

NCT03280303

Last updated date
Study Location
St. Luke's University Health Network - Sacred Heart Hospital
Allentown, Pennsylvania, 18102, United States
Contact
1-800-718-1021

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]

Call Now

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.


-

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Breast Cancer, Metastatic Breast CancerPalbociclib in Real World Practice
NCT03280303
  1. Allentown, Pennsylvania
  2. Burnaby, British Columbia
  3. Alabaster, Alabama
  4. Bessemer, Alabama
  5. Birmingham, Alabama
  6. Birmingham, Alabama
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  12. Little Rock, Arkansas
  13. Stuttgart, Arkansas
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  18. Chico, California
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  24. Newport Beach, California
  25. Orange, California
  26. Petaluma, California
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  30. Sacramento, California
  31. Saint Helena, California
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  90. Marietta, Georgia
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  95. Snellville, Georgia
  96. Arlington Heights, Illinois
  97. Bourbonnais, Illinois
  98. Chicago, Illinois
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  102. Joliet, Illinois
  103. Libertyville, Illinois
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  220. Eugene, Oregon
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  229. Harrisburg, Pennsylvania
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  273. Chesapeake, Virginia
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  278. Leesburg, Virginia
  279. Mechanicsville, Virginia
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  284. Nassawadox, Virginia
  285. Newport News, Virginia
  286. Norton, Virginia
  287. Richmond, Virginia
  288. Richmond, Virginia
  289. Suffolk, Virginia
  290. Virginia Beach, Virginia
  291. Williamsburg, Virginia
  292. Seattle, Washington
  293. Vancouver, Washington
  294. Bridgeport, West Virginia
  295. Huntington, West Virginia
  296. Huntington, West Virginia
  297. Morgantown, West Virginia
  298. Parkersburg, West Virginia
  299. Mississauga, Ontario
  300. Toronto, Ontario
  301. Chicoutimi, Quebec
  302. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Palbociclib in Real World Practice
Official Title POLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY
Brief Summary This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood
Sampling Method Probability Sample
Study Population 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.
Condition
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
Intervention Other: non-interventional
Study Groups/Cohorts non-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 Status Recruiting
Estimated Enrollment
 (submitted: September 8, 2017)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 6, 2021
Estimated Primary Completion Date January 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Canada,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03280303
Other Study ID Numbers A5481082
POLARIS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2019