HER2-low Breast Cancer, HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer
Conditions
Keywords
Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer, Real-world Data
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 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.
Interventions
OTHERNo drug
This is a non-interventional study and no study drug will be provided.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer | Index date to the end of the study period (approximately December 31, 2022) | Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause. |
| 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 | Index date to the end of the study period (approximately December 31, 2022) | 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. |
Countries
United States
Outcome results
None listed