Palbociclib in Real World Practice

Study Overview
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Brief Summary
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This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Official Title
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POLARIS: PALBOCICLIB IN HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER: A PROSPECTIVE MULTICENTER NON-INTERVENTIONAL STUDY

Conditions
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Advanced Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
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* Other: non-interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age ≥18 years or older. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent. Documented HR+ (ER+ and/or PR+) tumor based on local standards. Documented HER2- tumor based on local standards. Physician has determined that treatment with palbociclib is indicated. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 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: Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator's judgment. 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). Patients on active treatment for malignancies other than ABC at the time of enrollment. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-interventional study<br>This prospective, observational study will be conducted according to each site's routine clinical practice. | Other: non-interventional<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | 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 | Reporting will be based on sample size and follow up time through 2022. | 
| Patient quality of life, as measured by EORTC QLQ-C30 | 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. | Reporting will be based on sample size and follow up time through 2022. | 
| Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by G8 Screening Tool | 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. | Reporting will be based on sample size and follow up time through 2022. | 
| Geriatric Assessments in patients equal to or greater than 70 years of age at enrollment, as assessed by Activities of Daily Living | 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). | Reporting will be based on sample size and follow up time through 2022. | 
| Biomarker Assessment | 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. | Reporting will be based on sample size and follow up time through 2022. |