Clinical trial · Interventional
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
NCT05880927CI-TRIAL-00066755unknownPhase 2ClinicalTrials.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 trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant 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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pyrotinib 400mg/day
- description
- High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
- interventionNames
- Drug: Pyrotinib
Primary outcomes (1)
- measure
- iDFS
- timeFrame
- From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months
- description
- INVASIVE DISEASE FREE SURVIVAL
Secondary outcomes (2)
- measure
- OS
- timeFrame
- From date of receiving drug until the date of death from any cause, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18-75 years old 2. HER2 positive breast cancer 3. ECOG PS 0-1 4. Known hormone receptor status 5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months 6. Patients at high risk Exclusion Criteria: 1. Serious heart disease or discomfort 2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption 3. Known allergic history of drug components of this regimen 4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation 5. Pregnant and lactating female patients
References
Publications (1)
- DERIVEDCao F, Ma Z, Wu Z, Wu W, Wang O, Cui B, Zhu X, Hao J, Ji X, Li Z, Tao D, Feng Q, Lin W, Shi D, Shu J, Zhou J, Huang S. Pyrotinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (PERSIST): A multicenter phase II trial. Elife. 2025 Apr 3;13:RP101724. doi: 10.7554/eLife.101724. PMID 40178527