Clinical trial · Observational
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
NCT04158505CI-TRIAL-00044819unknownClinicalTrials.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 Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.
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 |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- non-interventional study
- interventionNames
- Other: non-interventional
Primary outcomes (3)
- measure
- Progression Free Survival(PFS)
- timeFrame
- 12 months
- description
- Progression Free Survival(PFS)
- measure
- Pathological Complete Response（pCR）Rate
- timeFrame
- through study completion, an average of 1 year
- description
- Percentage of Participants With Pathological Complete Response
- measure
- Incidences of adverse events and toxicities
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years old with histologically confirmed HER2 positive breast cancer. 2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive. 3. Physician has determined that treatment with pyrotinib is indicated. 4. Traceable medical record available. Exclusion Criteria: 1. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent . 2. Pregnant or breast feeding patients 3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. 4. Patients not suitable for this study under investigators' consideration.
References
Publications (0)
Data not yet available
No reference posted for this study.