Status:
COMPLETED
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hormone-receptor-positive Breast Cancer
HER2-low Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 endocri...
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients who received HER2-targeted therapies including
- Trastuzumab
- Pertuzumab
- Ado-trastuzumab emtansine
- Neratinib
- Tucatinib
- Lapatinib
- Fam-trastuzumab deruxtecan-nxki
- Margetuximab
Key Trial Info
Start Date :
July 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
927 Patients enrolled
Trial Details
Trial ID
NCT06040593
Start Date
July 31 2023
End Date
February 23 2024
Last Update
February 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ConcertAI database
Cambridge, Massachusetts, United States, 02138