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

Last updated: May 9, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No drug

Clinical Study ID

NCT06975371
U31402-0012-NIS-MA
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria

  • 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)

Exclusion Criteria

• 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

Study Design

Total Participants: 2200
Treatment Group(s): 1
Primary Treatment: No drug
Phase:
Study Start date:
April 14, 2025
Estimated Completion Date:
May 30, 2025

Study Description

This analysis will assess real-world outcomes in HR+/HER2- mBC patients who initiated a subsequent line of therapy (LOT) (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i. This study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population.

Connect with a study center

  • Flatiron Health, Inc

    New York, New York 10013
    United States

    Active - Recruiting

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