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There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.
This retrospective, non-interventional study is designed to assess the following primary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2-low Breast Cancer | Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. |
| |
| HR+/HER2-negative Breast Cancer | Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No drug | Other | This is a non-interventional study and no study drug will be provided. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer | Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause. | Index date to the end of the study period (approximately December 31, 2022) |
| Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer | Index date to the end of the study period (approximately December 31, 2022) | |
| Pathological Complete Response (pCR) in Participants With HR+ and HER2-Low/Negative Breast Cancer | Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy. | Index date to the end of the study period (approximately December 31, 2022) |
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Inclusion Criteria:
Exclusion Criteria:
Patients who received HER2-targeted therapies including
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Patients with HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 and treated with neoadjuvant chemotherapy or endocrine therapy will be identified from the ConcertAI database based on the inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ConcertAI database | Cambridge | Massachusetts | 02138 | United States |
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