Status:
COMPLETED
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
Lead Sponsor:
MedSIR
Collaborating Sponsors:
Daiichi Sankyo
AstraZeneca
Conditions:
Early Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
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 rec...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female patients who have at least 18 years of age at enrollment.
- 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
- 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%
- 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:
- Medical charts at Hospital that cannot guarantee reliable and congruent EHRs.
- If sufficient data cannot be obtained from EHRs.
Exclusion
Key Trial Info
Start Date :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
18533 Patients enrolled
Trial Details
Trial ID
NCT05217381
Start Date
February 22 2022
End Date
September 20 2023
Last Update
September 25 2023
Active Locations (7)
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1
Hospital del Mar
Barcelona, Spain
2
Hospital Sant Joan Despí - Moisès Broggi
Barcelona, Spain
3
Hospital Universitari Son Espases
La Palma, Spain
4
Hospital Universitario 12 de Octubre
Madrid, Spain