Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
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
- Advanced/Metastatic HER2-negative Breast Cancer
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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
New York, New York 10013
Site Coordinator
More Details
- NCT ID
- NCT06975371
- Status
- Recruiting
- Sponsor
- Daiichi Sankyo
Study Contact
Daiichi Sankyo Contact for Clinical Trial Information908-992-6400
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.