Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status

MedSIR18,533 enrolled

Overview

This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).

Patients with pathologically documented an initial breast cancer diagnostic (early breast cancer (BC) or locally advanced BC or de novo metastatic BC) with documented human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER)/progesterone receptor (PgR) expression status at the time of diagnosis. Data to determine the primary endpoint is estimated to be derived from the EHRs of over 2,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo metastatic BC (mBC) between the 1st of January 2005 and the 31st of December 2021, and who had at least one subsequent relapse until the 31st of December 2021 in at least 10 clinical centers. The secondary endpoints utilize a larger collection of data from over 30,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo mBC between the 1st of January 2005 and the 31st of December 2021.

Study Type

OBSERVATIONAL

Enrollment

18,533

Conditions

Early Breast Cancer Metastatic Breast Cancer Locally Advanced Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients who have at least 18 years of age at enrollment. 2. Patients with initial diagnosis of early BC or locally advanced BC or de novo mBC between the 1st of January 2005 and the 31st of December 2021 3. Pathologically documented BC for: * HER2 receptor expression with a validated assay according to American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) recommendations at the time of diagnosis. HER2 receptor expression can be: o HER2-positive expression: defined as immunohistochemistry (IHC) 3+ or concurrent IHC 2+ with in situ hybridization (ISH) positive or HER2-low expression: defined as IHC 2+ with ISH-negative or IHC 1+ with ISH-negative or untested) or HER2-negative expression: defined as IHC: 0. * Estrogen receptor \[ER\]- and/or progesterone receptor \[PgR\] with a validated assay according to ASCO/CAP guidelines at the time of diagnosis during early and/or advanced setting. ER/PgR expression can be: positive: ER or PgR ≥1% or negative: ER and PgR \<1% 4. Electronic Health Records (EHRs), with guaranteed data to meet requisites, about clinicopathological characteristics, type of surgery, treatment management, disease outcomes, and genomic profile. Centers that agree to participate must commit to include all subjects who meet the inclusion criteria, in order to reduce possible selection bias. Exclusion criteria: 1. Medical charts at Hospital that cannot guarantee reliable and congruent EHRs. 2. If sufficient data cannot be obtained from EHRs.

Locations (7)

Hospital del Mar

Barcelona, Spain

Hospital Sant Joan Despí - Moisès Broggi

Barcelona, Spain

Hospital Universitari Son Espases

La Palma, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Outcomes

Primary Outcomes

Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses

Change in HER2 expression between initial diagnosis of early BC or locally advanced BC or de novo mBC and any of subsequent BC relapses by IHC and/or ISH validated assays.

Time frame: 180 months

Secondary Outcomes

Prevalence of changes in HER2 expression among different lines of treatment

HER2 expression changes as assessed by IHC (0+, 1+, 2+, 3+) and/or ISH (positive or negative) validated assays among different lines of treatment in the advanced setting, and/or among different metastatic sites.

Time frame: 180 months

Description of the clinicopathological characteristics

Description of all the comprehensive clinicopathological characteristics (age at diagnosis, gender \[male or female\], baseline Eastern Cooperative Oncology Group \[ECOG\] performance status \[0, 1, or 2\], breast cancer pathological subtype at primary site, intrinsic subtype at primary and/or metastatic site by PAM50 test \[including luminal A, luminal B, HER2-overexpressing, and basal-like\], ER and PgR status \[positive and/or negative\] at primary and/or metastatic site, HER2 status by IHC and/or ISH testing \[HER2-positive, HER2-low expressing, and HER2-negative status per ASCO-CAP guidelines\] at primary and/or metastatic site, Ki67 at primary and/or metastatic site, endocrine resistance \[primary or secondary\]), metastatic sites (bone, brain, visceral involvement) nodal involvement, presence of measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) in all patients enrolled.

Time frame: 180 months

Evaluation of the disease management

Description of disease management and treatment patterns in all patients enrolled for gaining contemporary insights into HER2-low expressing breast cancer treatment trends that may inform clinicians for future management plans.

Time frame: 180 months

Data from ClinicalTrials.gov

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