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.|
|ClinicalTrials.gov Identifier: NCT03280303|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment|
|Advanced Breast Cancer Metastatic Breast Cancer||Other: non-interventional|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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|
This prospective, observational study will be conducted according to each site's routine clinical practice.
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
Show 291 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|