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

July 7, 2022 updated by: Pfizer

Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • Pfizer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
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.
Drug: Palbociclib + Letrozole
Palbociclib + Letrozole therapy
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.
Drug: Letrozole
Letrozole monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world progression free survival (rwPFS)
Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months
Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months
From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.
From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 52 months
Real-world tumor response (rwTR)
Time Frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months
Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment
From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months
Time to next line of therapy
Time Frame: From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Time to first use of chemotherapy
Time Frame: From date of index treatemnt to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months
Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months
From date of index treatemnt to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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/data_requests.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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