NCT07274709|CompletedFDA Drug
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Food and Drug Administration
observational
2,495
1 country
1
Study Start
September 7, 2025
Actual (reported)Primary Completion
January 1, 2026
Actual (reported)Study Completion
January 1, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2025
Actual (reported)November 20, 2025
Actual (reported)December 10, 2025
Actual (reported)January 1, 2026
Actual (reported)January 1, 2026
Actual (reported)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)
Exposure group
Reference group
Initiation of ribociclib plus letrozole described in electronic health records is used as the exposure
Initiation of letrozole described in electronic health records is used as the reference
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.
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
Shirley Wang, PhD, ScM
Brigham and Women's Hospital
Denys Shay, MD
Brigham and Women's Hospital
2,495 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2025
First Posted
December 10, 2025
Study Start
September 7, 2025
Actual (reported)A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2026
Actual (reported)Study Completion
January 1, 2026
Actual (reported)Last Updated
May 12, 2026
Record last verified: 2025-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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