Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i

Completed

Conditions studied: Advanced/Metastatic HER2-negative Breast Cancer

In brief

This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.

Key facts

Study ID

NCT06975371

Run by

Daiichi Sankyo

People needed

1415

Starts

2025-04-14

Expected to finish

2025-08-05

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with evidence of Stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2017
• 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)

You may not qualify if…

• A record of estrogen receptor 1 (ESR1), phosphatidylinositol4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), V-akt murine thymoma viral oncogene homolog (AKT1), phosphatase and tensin homolog (PTEN), or germline breast cancer gene (gBRCA) alteration/mutation prior to or within 30 days after index treatment date

Where it is running

• Flatiron Health, Inc — New York, New York, United States

Full record on ClinicalTrials.gov

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