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OpenTrials
Completed

NCT Number: NCT06975371

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Flatiron Health, Inc

New York, 10013, United States

About this study

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. No study drug was administered in this non-interventional study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No drug

Other

No study drug was administered in this non-interventional study.

Primary outcomes

  1. Real-world progression-free survival (rwPFS)

    Time frame: Baseline up to end of observation period, approximately 7 years 9 months

    Real-world progression-free survival (rwPFS) will be calculated as the time from the index treatment date to the date of the first documented rwP event occurring >14 days after the index treatment date or date of death, whichever occurs first.

Secondary outcomes

  1. Real-world overall survival (rwOS)

    Time frame: Baseline up to end of observation period, approximately 7 years 9 months

    Real-world overall survival (rwOS) will be calculated as the time from the index treatment date to death. Patients who do not experience the event of interest (death) will be censored at their last confirmed activity date.

  2. Real-world time to discontinuation or death (rwTTD/D)

    Time frame: Baseline up to end of observation period, approximately 7 years 9 months

    Real-world time to treatment discontinuation or death (rwTTD/D) will be calculated for the index LOT. For the set of drugs contained in the index LOT, rwTTD/D will be calculated as the time from the first drug episode to the last drug episode or death, whichever comes first.

  3. Real-world time to next treatment or death (rwTTNT/D)

    Time frame: Baseline up to end of observation period, approximately 7 years 9 months

    Real-world time to next treatment or death (rwTTNT/D) will be calculated for the index LOT as the time from the start of the LOT to the initiation of next LOT or death, whichever comes first.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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