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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: No drug
    No study drug was administered in this non-interventional study.

Recruiting Locations

Flatiron Health, Inc
New York, New York 10013
Contact:
Site Coordinator

More Details

NCT ID
NCT06975371
Status
Recruiting
Sponsor
Daiichi Sankyo

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information
908-992-6400
CTRinfo_us@daiichisankyo.com

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 also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center