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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

724 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-01

Study Completion Date

2023-07-20

Brief Summary

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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?

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Detailed Description

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The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCT) as a benchmark for causal effect estimates, a series of RCT emulations will be conducted across varying trials, real world data sources, and study design elements to better understand under what conditions non-interventional studies, using data generated during routine clinical care, can provide reliable conclusions about drug effectiveness.

In this study, real-world electronic health record (EHR) data will be used to emulate the Palbociclib: Ongoing Trials in the Management of Breast Cancer (PALOMA-2) efficacy 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.2 Similarly to the PALOMA-2 trial, this study will compare real-world progression-free survival (rwPFS) between patients who initiate palbociclib and letrozole and those initiating letrozole alone.

Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed

Patients initiating treatment with palbociclib and letrozole as first-line treatment for metastatic ER+/HER2- breast cancer

Palbociclib

Intervention Type DRUG

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

Letrozole

Intervention Type DRUG

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

Comparator

Patients initiating treatment with letrozole as first-line treatment for metastatic ER+/HER2- breast cancer

Letrozole

Intervention Type DRUG

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

Interventions

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Palbociclib

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

Intervention Type DRUG

Letrozole

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Breast cancer diagnosis
* Histology not indicative of non-adenocarcinoma histologies
* Metastatic disease
* Estrogen-receptor positive (ER+)
* No prior systemic treatment for metastatic breast cancer
* Post-menopausal
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or missing or Karnofsky performance status \>=50 or missing
* No lab results indicating inadequate organ function, as defined in the PALOMA-2 RCT protocol

Exclusion Criteria

* Human epidermal growth factor receptor 2 (HER2) positive tumor
* Diagnosis of brain, central nervous system, and/or spinal cord metastases
* Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
* Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
* Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
* Anti-cancer therapy or major cancer-related surgery within 2 weeks before study treatment initiation
* Diagnosis of a second primary malignancy within 3 years prior to study treatment initiation
* Diagnosis of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
* Diagnosis of hypocalcemia, hypokalemia, or hypomagnesemia
* Diagnosis of myocardial infarction, angina, ongoing cardiac dysrhythmias, atrial fibrillation, congestive heart failure, cerebral infarction, transient ischemic attack, or pulmonary embolism in the 6 months prior to study treatment initiation
* Diagnosis of inflammatory bowel disease chronic diarrhea, or short bowel syndrome
* Diagnosis of human immunodeficiency virus infection

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No