Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

NCT04176354

Last updated date
Study Location
Pfizer
New York, New York, 10017, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Female sex

2. At least 18 years old at MBC diagnosis

3. Diagnosis of MBC at any point in patient history

1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC

2. Confirmation of metastatic disease

3. At least 2 document clinical visits

4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents

4. HR+/HER2-

1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis

2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis

5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI
(Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or
Fulvestrant for MBC


2. First structured activity greater than 90 days after MBC diagnostic date


3. Treatment with a CDK4/6 inhibitor as part of a clinical trial

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Advanced Information
Descriptive Information
Brief Title Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
Official Title Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer
Brief Summary A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
Detailed Description Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.
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 HR+/HER2- MBC female adult patients treated with Palbociclib + AI or Letrozole alone between February2015 and end of 2018 or data cut-off date
Condition Metastatic Breast Cancer
Intervention
  • Drug: Palbociclib + an aromatase inhibitor
    Palbociclib + an aromatase inhibitor therapy
  • Drug: Palbociclib + Letrozole
    Palbociclib + Letrozole therapy
  • Drug: Letrozole
    Letrozole monotherapy
Study Groups/Cohorts
  • Palbociclib + an aromatase inhibitor
    Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
    Intervention: Drug: Palbociclib + an aromatase inhibitor
  • Palbociclib + Letrozole
    Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
    Intervention: Drug: Palbociclib + Letrozole
  • Letrozole
    Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
    Intervention: Drug: Letrozole
Publications * Not Provided

*   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: November 21, 2019)
1
Original Actual Enrollment Same as current
Estimated Study Completion Date October 27, 2021
Estimated Primary Completion Date October 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Female sex
  2. At least 18 years old at MBC diagnosis
  3. Diagnosis of MBC at any point in patient history

    1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
    2. Confirmation of metastatic disease
    3. At least 2 document clinical visits
    4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
  4. HR+/HER2-

    1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
    2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
  5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion Criteria:

  1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC
  2. First structured activity greater than 90 days after MBC diagnostic date
  3. Treatment with a CDK4/6 inhibitor as part of a clinical trial
Sex/Gender
Sexes Eligible for Study:Female
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 NCT04176354
Other Study ID Numbers A5481122
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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 May 2020