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This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.
This study will utilize a longitudinal, demographically and geographically diverse database derived from Electronic Health Record data. No study medication will be supplied or administered for this protocol. The primary research objective is to describe the real-world progression-free survival (rwPFS) in HER2+ mBC patients who initiated a subsequent line of therapy (LOT) after a T-DXd-containing LOT in the metastatic setting.
Secondary research objectives include describing the real-world overall survival (rwOS), patient demographics and clinical characteristics, real-world time to next treatment (rwTTNT), and real-world time to treatment discontinuation (rwTTD) in HER2+ mBC patients who initiated a subsequent LOT after a T-DXd-containing LOT in the metastatic setting. Treatment patterns and sequencing in HER2+ mBC patients for subsequent LOTs following initial treatment with T-DXd will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-positive breast cancer | Patients diagnosed with HER2-positive metastatic breast cancer who initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug | Other | This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Progression-free Survival (rwPFS) | rwPFS is defined as the interval in months between the index date until the first evidence of progression or death as documented by Flatiron. | Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world Time to Next Treatment (rwTTNT) | rwTTNT is defined as the time in months between index date and initiation of next LOT, or death, whichever occurs first. | Index date (index LOT start date) to next LOT start date or, in the absence of next LOT, death, whichever occurs first, up to approximately 13 years 3 months |
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Inclusion Criteria
Patients must meet all the inclusion criteria below to be included in the study population:
Exclusion Criteria No exclusion criteria will be imposed.
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The study population will consist of adults in the Flatiron mBC EDM who were diagnosed with HER2+ mBC during the study period and initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting.
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| Name | Affiliation | Role |
|---|---|---|
| Project Manager | 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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| Real-world Time to Treatment Discontinuation (rwTTD) |
rwTTD is defined as the time in months between index date and date of treatment discontinuation or death, whichever occurs first. |
| Index date (index LOT start date) to date treatment is discontinued, up to approximately 13 years 3 months |
| Treatment Patterns by Type of Line of Therapy | Treatment patterns will be described by LOT (monotherapy, combination therapy, and treatment sequence). | Index date (index LOT start date) to end of study period, up to approximately 13 years 3 months |