Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
NCT ID: NCT06975371
Last Updated: 2025-10-07
Study Results
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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COMPLETED
1415 participants
OBSERVATIONAL
2025-04-14
2025-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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HR+/HER2- metastatic breast cancer
Adults in the Flatiron database who are diagnosed with HR+/HER2- metastatic breast cancer and initiated a subsequent line of therapy (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i.
No drug
No study drug was administered in this non-interventional study.
Interventions
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No drug
No study drug was administered in this non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* Aged ≥18 years at mBC diagnosis date
* Received 1L ET + CDK 4/6i, with no other systemic agents, in the metastatic setting
* Had evidence of a rwP event during 1L ET + CDK 4/6i
* Evidence of a subsequent LOT following 1L ET + CDK 4/6i (start date of subsequent LOT = index treatment date)
* A record of HR+ status in the closest estrogen receptor (ER) or progesterone receptor (PR) test result occurring prior to or within 30 days after the index treatment date
* A record of HER2- status in the closest HER2 test result recorded prior to or on the index treatment date
* Index treatment date occurring at least 90 days prior to end of study period (30Sep2024)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Director
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Flatiron Health, Inc
New York, New York, United States
Countries
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Other Identifiers
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U31402-0012-NIS-MA
Identifier Type: -
Identifier Source: org_study_id
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