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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 : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Advanced Breast Cancer Metastatic Breast Cancer Other: non-interventional

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polaris: Palbociclib In Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-interventional Study
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 16, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Group/Cohort Intervention/treatment
non-interventional study
This prospective, observational study will be conducted according to each site's routine clinical practice.
Other: non-interventional



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Biospecimen Retention:   Samples With DNA
blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280303


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 275 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03280303     History of Changes
Other Study ID Numbers: A5481082
POLARIS ( Other Identifier: Alias Study Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action