Clinical trial · Observational
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2
NCT03908749CI-TRIAL-00038017unknownClinicalTrials.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)
To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.
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 Carcinoma | HER2-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- PFS
- timeFrame
- 1 year
- description
- Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
- measure
- pCR
- timeFrame
- 1 year
- description
- Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual
Secondary outcomes (6)
- measure
- OS
- timeFrame
- 1 year
- description
- overall survival is defined as the length of time from random assignment to death or to last contact.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients . 2. Confirmed by pathological examination of breast cancer patients with positive her-2 expression 3. The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable. 4. Patients should be voluntary to the trial and provide with signed informed consent 5. The researchers believe patients can benefit from the study. Exclusion Criteria: 1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories 2. Pregnant or lactating women 3. Patients with Pyrotinib maleate tablets contraindications 4. Patients of doctors considered unsuitable for the trial
References
Publications (0)
Data not yet available
No reference posted for this study.