ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
-
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Descriptive Information | |||||
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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 |
| ||||
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 Nov;16(31):2475-2485. doi: 10.2217/fon-2020-0573. Epub 2020 Aug 13. | ||||
* 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 | 1500 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | January 27, 2022 | ||||
Estimated Primary Completion Date | January 27, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria
Exclusion Criteria:
| ||||
Sex/Gender |
| ||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
| ||||
Listed Location Countries | Canada, United States | ||||
Removed Location Countries | Puerto Rico | ||||
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 |
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IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | January 2021 |