Last updated date
ABOUT THIS STUDY
To describe patient demographics, clinical characteristics, treatment patterns and clinical
outcomes of adult female patients who have received palbociclib combination treatments in
line with regional licensed indications in real world settings across multiple countries.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Malignant Neoplasm of Breast
Sex
Female
Age
0 +
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Advanced Information
Descriptive Information | |||||||
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Brief Title | Ibrance Real World Insights | ||||||
Official Title | TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS | ||||||
Brief Summary | To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries. | ||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication. | ||||||
Condition | Malignant Neoplasm of Breast | ||||||
Intervention | Not Provided | ||||||
Study Groups/Cohorts | Breast Cancer Patients
HR+/HER2- advanced/metastatic breast cancer patients across multiple countries. | ||||||
Publications * | Waller J, Mitra D, Mycock K, Taylor-Stokes G, Milligan G, Zhan L, Iyer S. Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. J Glob Oncol. 2019 May;5:JGO1800239. doi: 10.1200/JGO.18.00239. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment | 2968 | ||||||
Original Estimated Enrollment | 1200 | ||||||
Actual Study Completion Date | July 23, 2020 | ||||||
Actual Primary Completion Date | July 23, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Physician inclusion criteria
Patient inclusion criteria
Exclusion criteria: Physician exclusion criteria
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03159195 | ||||||
Other Study ID Numbers | A5481090 IRIS ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||||
Study Sponsor | Pfizer | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Pfizer | ||||||
Verification Date | October 2020 |