Clinical trial · Observational
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
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
NCT05217381CI-TRIAL-00069887RosHERcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Patients with an initial diagnostic of early breast cancer or locally advanced breast cancer or de novo metastatic breast cancer
Primary outcomes (1)
- measure
- Prevalence of HER2 expression change between initial diagnosis versus any of the subsequent BC relapses
- timeFrame
- 180 months
- description
- 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.
Secondary outcomes (9)
- measure
- Prevalence of changes in HER2 expression among different lines of treatment
- timeFrame
- 180 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.