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

Plain-language summary

This study examines the clinical and pathological characteristics and treatment management of breast cancer patients according to their HER2 status, using real-world data. It enrolled patients aged 18 and older diagnosed with early, locally advanced, or metastatic breast cancer between 2005 and 2021. It was an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

MedSIR

Start date

2/22/2022

Estimated completion

9/20/2023

Countries

Spain

Related genes

Locations

• Barcelona, Spain
• Barcelona, Spain
• La Palma, Spain
• Madrid, Spain
• Madrid, Spain
• Pamplona, Spain
• Santander, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.