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Status:

COMPLETED

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

Lead Sponsor:

Daiichi Sankyo

Conditions:

Advanced/Metastatic HER2-negative Breast Cancer

Eligibility:

All Genders

18+ years

Brief 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 w...

Detailed 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 a...

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

Exclusion

    Key Trial Info

    Start Date :

    April 14 2025

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 5 2025

    Estimated Enrollment :

    1415 Patients enrolled

    Trial Details

    Trial ID

    NCT06975371

    Start Date

    April 14 2025

    End Date

    August 5 2025

    Last Update

    October 7 2025

    Active Locations (1)

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    Flatiron Health, Inc

    New York, New York, United States, 10013