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

Completed

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

In brief

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.

Key facts

Study ID

NCT06040593

Run by

Daiichi Sankyo

People needed

927

Starts

2023-07-31

Expected to finish

2024-02-23

Last updated by the study team

2024-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Patients who received HER2-targeted therapies including
• Trastuzumab
• Pertuzumab
• Ado-trastuzumab emtansine
• Neratinib
• Tucatinib
• Lapatinib
• Fam-trastuzumab deruxtecan-nxki
• Margetuximab

Where it is running

• ConcertAI database — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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