Clinical trial NCT05217381: Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
Official title: Retrospective Observational Study With Real-World Data to Assess Demographic and Clinicopathological Profiles, and Management of Breast Cancer Patients With Positive, Low or Negative Expression of HER2 in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Breast Cancer
Metastatic Breast Cancer
Locally Advanced Breast Cancer
Keywords: Breast Cancer
Real-World Data
HER2 negative
HER2 positive
HER2 low
Artificial Intelligence
Lead sponsor: MedSIR
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
name: AstraZeneca
First posted: 2022-02-01
Enrollment: 18533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an initial confirmed diagnostic of breast cancer (early or locally advanced or de novo metastatic) managed in clinical practice during the predefined timeframe in the selected hospitals.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses
timeFrame: 180 months
Secondary outcomes:
measure: Prevalence of changes in HER2 expression among different lines of treatment
timeFrame: 180 months
measure: Description of the clinicopathological characteristics
timeFrame: 180 months
measure: Evaluation of the disease management
timeFrame: 180 months
measure: Description of genomic profile
timeFrame: 180 months
measure: Efficacy (OS)
timeFrame: 180 months
measure: Efficacy (ORR)
timeFrame: 180 months
measure: Efficacy (CBR)
timeFrame: 180 months
measure: Efficacy (PFS)
timeFrame: 180 months
measure: Efficacy (DoR)
timeFrame: 180 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant Joan Despí - Moisès Broggi
city: La Palma
country: Spain
facility: Hospital Universitari Son Espases
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundación de Alcorcón
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra (CUN)
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
Study officials:
affiliation: MedSIR
name: Javier Cortés, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: