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Palbociclib in Real World Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03280303
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : December 21, 2021
Information provided by (Responsible Party):

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

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT03280303

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Contact: Pfizer Call Center 1-800-718-1021

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT03280303    
Other Study ID Numbers: A5481082
POLARIS ( Other Identifier: Alias Study Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (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:

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases