Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases

NCT07274709 | Completed FDA Drug

• 2 other identifiers: 2022P002556-ENC-MONALEESA-275F40122C00181
• Study Type: observational
• Target: 2,495
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to all-cause mortality/overall survival (OS)

  Hazard ratio (95% CI)

  From time of initiation of therapy through the earliest of death from any cause (the primary outcome of interest) or end of data availability (depending on specialty oncology registry data provider, end of data ranges from June 2023 to April 2024)

Study Arms (2)

Initiation of ribociclib plus letrozole

Exposure group

Drug: Initiation of ribociclib

Initiation of letrozole

Reference group

Drug: Initiation of ribociclib; Drug: Initiation of letrozole

Interventions

Initiation of letrozole DRUG

Initiation of letrozole described in electronic health records is used as the reference

Initiation of letrozole

Initiation of ribociclib DRUG

Initiation of ribociclib plus letrozole described in electronic health records is used as the exposure

Initiation of letrozole; Initiation of ribociclib plus letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with hormone receptor (HR)-positive \[estrogen receptor (ER) and/or progesterone receptor (PR)\], human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.

You may qualify if:

• Age ≥18 years through 2017 to 2023
• Metastatic breast cancer
• Hormone receptor positive (ER/PR+)
• Untreated with systemic anticancer therapy for advanced disease
• ECOG performance status of 0 or 1
• HER2-negative

You may not qualify if:

• Prior treatment with CDK4/6 inhibitor
• Locally advanced (unresectable) or inflammatory breast cancer
• Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix
• Prior adjuvant therapy for breast cancer
• Systemic anticancer therapy other than ribociclib or letrozole

Sponsors & Collaborators

• Shirley Vichy Wang: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Denys Shay, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 10, 2025
• Study Start: September 7, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-11

Locations

US (1)