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Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases

NCT ID: NCT07225790

Last Updated: 2025-11-10

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

ACTIVE_NOT_RECRUITING

Total Enrollment

3883 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-03

Study Completion Date

2026-01-31

Brief Summary

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Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Detailed Description

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Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to complement evidence from RCTs. Yet, to have confidence in the accuracy of non-interventional studies medical products and their outcomes in oncology, investigators need to know what questions can be validly answered, with which non-interventional study designs, and which analysis methods are appropriate, given the data that is available. Building on a process from the RCT DUPLICATE initiative1-4 EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) is part of the expansion project specific to oncology and aims to emulate 12 randomized oncology RCTs using multiple EHR data sources.

The purpose of this protocol is to describe the emulation of the MONARCH-3 trial. MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole/anastrozole, daily.

Conditions

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Advanced Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Initiation of abemaciclib plus letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

Initiation of abemaciclib plus letrozole/anastrozole

Intervention Type DRUG

Any doses and frequency observed in clinical practice will be allowed

Initiation of letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

Initiation of letrozole/anastrozole

Intervention Type DRUG

Any doses and frequency observed in clinical practice will be allowed

Interventions

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Initiation of abemaciclib plus letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

Intervention Type DRUG

Initiation of letrozole/anastrozole

Any doses and frequency observed in clinical practice will be allowed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female aged ≥18 years at treatment initiation from 2017 - 2023
* Evidence of metastatic breast cancer (MBC)
* Documentation of Estrogen/Progesterone receptor-positive (ER/PR+)
* Documentation of Human Epidermal Growth Factor Receptor Negative (HER2-)
* ECOG performance status of 0 or 1 within 90 days of index date

Exclusion Criteria

* CNS metastases
* Prior treatment with CKD4/6 inhibitor
* Prior or current treatment with chemotherapy or endocrine therapy other than letrozole/anastrozole for systemic anticancer therapy for MBC.
* Prior (neo-)adjuvant endocrine therapy
* Systemic anticancer therapy other than abemaciclib or letrozole/anastrozole
* Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shirley Vichy Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Denys Shay, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2022P002556-ENC-MONARCH-3

Identifier Type: -

Identifier Source: org_study_id