Ibrance Real World Insights [IRIS]

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NCT03159195

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Study Location
Pfizer, Inc.
New York, New York, 10017, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malignant Neoplasm of Breast
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Malignant Neoplasm of BreastIbrance Real World Insights [IRIS] NCT03159195
  1. New York, New York
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Ibrance Real World Insights [IRIS]
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 Drug: Palbociclib
CDK 4/6 inhibitor for advanced/ metastatic breast cancer
Other Name: Ibrance
Study Groups/Cohorts Not Provided
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 Active, not recruiting
Actual Enrollment
 (submitted: June 24, 2019)		700
Original Estimated Enrollment
 (submitted: May 17, 2017)		1200
Estimated Study Completion Date June 3, 2020
Estimated Primary Completion Date June 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA

  • ?18 years old
  • HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
  • Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s)
  • No prior or current enrolment in an interventional clinical trial for ABC/MBC
  • Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review)
  • Minimum of three months of follow up data since palbociclib initiation (interim medical record review)
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Gender Eligibility Description:Female participants only
Ages 18 Years and older   (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
Studies a U.S. FDA-regulated Device Product: No
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019