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

Daiichi Sankyo927 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

927

Conditions

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

Interventions

No drugOTHER

This is a non-interventional study and no study drug will be provided.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ConcertAI database

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

Event-free survival (EFS) in Participants With HR+ and HER2-Low/Negative Breast Cancer

Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.

Time frame: Index date to the end of the study period (approximately December 31, 2022)

Overall Survival of Participants With HR+ and HER2-Low/Negative Breast Cancer

Time frame: 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

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.

Time frame: Index date to the end of the study period (approximately December 31, 2022)

Data from ClinicalTrials.gov

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