Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This retrospective, non-interventional study is designed to assess the following primary objectives: To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.

Official Title
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Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy

Conditions
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Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer

Intervention / Treatment
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* Other: No drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis) Stage I-IIIB at the time of diagnosis Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy Received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or IO therapy) Exclusion Criteria: Patients who received HER2-targeted therapies including Trastuzumab Pertuzumab Ado-trastuzumab emtansine Neratinib Tucatinib Lapatinib Fam-trastuzumab deruxtecan-nxki Margetuximab

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HR+/HER2-low Breast Cancer<br>Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. | Other: No drug<br>* This is a non-interventional study and no study drug will be provided.<br>|
| HR+/HER2-negative Breast Cancer<br>Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases. | Other: No drug<br>* This is a non-interventional study and no study drug will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer, Real-world Data