Clinical trial · Observational
RWD Study in HER2+ mBC Patients in Third-Line Therapy
Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
NCT04566458CI-TRIAL-00054335completedClinicalTrials.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 retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single arm
- description
- Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.
- interventionNames
- Other: No intervention
Primary outcomes (7)
- measure
- To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada
- timeFrame
- up to 2 years
- description
- The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
- measure
- To describe the brain metastatic HER2+ mBC subpopulation during third line
- timeFrame
- up to 2 years
- description
- The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Male or female patients (≥18 years of age) Patients with stage IV breast cancer Patients with HER2+ status in metastatic setting Patients that received at least two lines of active anti-cancer drugs due to disease progression. Patients that began third-line therapy prior to October 31, 2018. Exclusion Criteria: Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
References
Publications (0)
Data not yet available
No reference posted for this study.