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Palbociclib in Real World Practice

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ClinicalTrials.gov Identifier: NCT03280303
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 1, 2017
First Posted Date September 12, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date January 1, 2017
Estimated Primary Completion Date January 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2017)
  • Clinical outcome [ Time Frame: Reporting will be based on sample size and follow up time through 2022. ]
    Progression free survival: the time from the start date of palbociclib to the date of the progression of disease or death according to investigator's assessment
  • Patient quality of life, as measured by EORTC QLQ-C30 [ Time Frame: Reporting will be based on sample size and follow up time through 2022. ]
    EORTC QLQ-C30 is used to assess changes in quality of life for patients undergoing treatment for cancer. It is a 30-item questionnaire assessing other cancer-related symptoms, with responses based on recall during the past week.
  • Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by G8 Screening Tool [ Time Frame: Reporting will be based on sample size and follow up time through 2022. ]
    The G8 Screening Tool is a physician-assessed tool to identify geriatric cancer patients for comprehensive geriatric assessment to evaluate an older person's functional ability, physical health, cognition and mental health, and socioenvironmental circumstances.
  • Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by Activities of Daily Living [ Time Frame: Reporting will be based on sample size and follow up time through 2022. ]
    Activities of daily living assesses patient basic self-care skills to maintain independence in home (bathing, dressing toileting, feeding oneself, maintain continent, transferring from bed/chair).
  • Biomarker Assessment [ Time Frame: Reporting will be based on sample size and follow up time through 2022. ]
    Exploratory research question for investigating potential mechanism of response and resistance to palbociclib treatment, through genomic analyses in the blood samples collected at standard of care intervals.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 * Tripathy D, Blum JL, Rocque GB, Bardia A, Karuturi MS, Cappelleri JC, Liu Y, Zhang Z, Davis KL, Wang Y. POLARIS: a prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer. Future Oncol. 2020 Aug 13. doi: 10.2217/fon-2020-0573. [Epub ahead of print]

*   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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2019