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Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy | Clinical Trials | Clareo Health

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

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

NCT04176354•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+1 more criteria

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

Locations (1)

Pfizer

New York, New York, United States

Key Dates

Start Date

January 25, 2019

Primary Completion Date

September 27, 2019

Completion Date

September 27, 2019

Last Updated

August 23, 2024

Enrollment

813

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Palbociclib + an aromatase inhibitor

DRUG

Palbociclib + Letrozole

DRUG

Letrozole

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

A Study of Surgery and Radiotherapy in People With Breast Cancer