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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug | Other | No study drug was administered in this non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world progression-free survival (rwPFS) | 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. | Baseline up to end of observation period, approximately 7 years 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world overall survival (rwOS) | 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. | Baseline up to end of observation period, approximately 7 years 9 months |
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Inclusion criteria
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
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The study cohort consists of adults in the Flatiron database who are diagnosed with HR+/HER2- mBC and initiated a subsequent LOT (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i.
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| Name | Affiliation | Role |
|---|---|---|
| Director | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flatiron Health, Inc | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Real-world time to discontinuation or death (rwTTD/D) |
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. |
| Baseline up to end of observation period, approximately 7 years 9 months |
| Real-world time to next treatment or death (rwTTNT/D) | 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. | Baseline up to end of observation period, approximately 7 years 9 months |
| D017437 |
| Skin and Connective Tissue Diseases |