NCT06040593

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 927 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

This retrospective, non-interventional study is designed to assess the following primary objectives: 1. 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 2. 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.

Conditions

• Hormone-receptor-positive Breast Cancer
• HER2-low Breast Cancer
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
OTHER	No drug	This is a non-interventional study and no study drug will be provided.

Timeline

• Start date: 2023-07-31
• Primary completion: 2023-11-30
• Completion: 2024-02-23
• First posted: 2023-09-15
• Last updated: 2024-02-26

Locations

1 site across 1 country: United States