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CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

NCT06607601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 724

Last updated 2024-09-23

No results posted yet for this study

Summary

The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer using real-world, electronic health record data. The main questions this study aims to answer are:

1. Do patients with metastatic ER+/HER2- breast cancer treated with palbociclib and letrozole have improved real-world progression-free survival (rwPFS) compared with patients treated with letrozole alone?
2. How do the results of this non-interventional study compare to those of the PALOMA-2 randomized controlled trial?

Conditions

Interventions

DRUG

Palbociclib

Treatment information in the electronic health record indicates initiation of palbociclib after metastatic diagnosis

DRUG

Letrozole

Treatment information in the electronic health record indicates initiation of letrozole after metastatic diagnosis

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Janssen, LP

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Aetion, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2023-07-20
Completion
2023-07-20
FDA Drug
Yes

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Entities

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607601 on ClinicalTrials.gov