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

Daiichi Sankyo

Status: Completed

Conditions: Hormone-receptor-positive Breast Cancer; HER2-low Breast Cancer; HER2-negative Breast Cancer

Treatments: Other: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06040593

U31402-0005-NIS-EPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 927 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

927 participants in 2 patient groups

HR+/HER2-low Breast Cancer

Description:

Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

Treatment:

Other: No drug

HR+/HER2-negative Breast Cancer

Description:

Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

Treatment:

Other: No drug